gastric band mri safety

Good safety profile (low migration and erosion rate) One model of this has a titanium port, and the other model is plastic. Note that these devices are not common and are typically used to treat Gastroparesis where patients will typically experience symptoms such as vomiting and nausea. Read MR Safety Disclaimer Before Proceeding, HX201LR-135L by Olympus). If this helps - before I had the MRI for my shoulder, they asked me if I worked around metal and could any pieces have gotten into my eye. The band's slip-through buckle design makes laparoscopic placement around the stomach easier, allowing the formation of a small gastric pouch and stoma. The band constriction can then be assessed by barium swallow. Explant and replacement surgery may be required. Conditional 7 More. A gastric band is a popular form of bariatric surgery and is a surgically placed device, used to assist in weight loss and is adjustable. Your Resource for MRI Safety, Bioeffects,& Patient Management. By clicking Accept, you consent to the use of all cookies. The BioEnterics LAP-BAND System is designed to induce weight loss in severely obese patients by limiting food consumption. No. Lap Band on 01/20/10. The Lap-Band System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions. Urgent Field Safety Notice . Information regarding the clinical trial can be found here: Cavu Medicals Attune device was implanted as part of an Australian Clinical Trial. I had MRIs done while banded, no problem. There are LINX systems that are designed to be safe for MRIs. Notwendige Cookies sind unbedingt erforderlich, damit die Website ordnungsgem funktioniert. Watch our free, no-obligation online seminar to get started with the Lap-Band. Gastroesophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter (LES). 4. I also have a call into my MRI dr's office, but just wondering if people here have had any issues with their bands and MRIs. It was caused by the band damaging the Vagus nerve system. ), we believe only 40 patients had these devices implanted, at a couple of sites in Australia between Oct 2010 and July 2011. To provide the best experiences, we use technologies such as cookies to store and/or access device information. MIDBAND TM FEATURES The MIDBAND TM gastric band is implantable with a 12 mm trocar and easy to detect with X-Ray Imaging. Lap-Band1001 Calle AmanecerSan Clemente, CA 92673. Reoperation may be required. Sun-Flex, MAC 4, 304 SS. the band's slip-through buckle design makes laparoscopic placement around the stomach I'd suggest calling the radiologist so they can take a look. Important: For full safety information please click here or talk with your doctor. Find safety related information pertaining to thousands of specific implants or devices. catheterSmiths Medical ASD, Inc.Southington, CT, Acuvance PlusPUR RadiopaqueIntravenous (I.V.) The REALIZE band, from a different manufacturer, seems similar. The storage or technical access is necessary to create user profiles in order to send advertisements, or to follow the user on a website or on several websites for similar marketing purposes. Urgent Field Safety Notice . Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. Glad to hear it's not referred left shoulder pain, not that rotator cuff pain is any better! Radiographical imaging of the normal anatomy and complications after gastric banding. document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Complications of adjustable gastric banding, a radiological pictorial review. LAP-BAND Adjustable Gastric Banding System FSN-20-001 . Procedure Performed laparoscopically, a silicone band device is placed around the stomach to reduce its vo. The overwhelming majority of Gastric Band devices are MR Conditional with conditions that are fairly typical and straightforward to satisfy. I can live LIFE., As you use our website, we and our third-party providers use cookies to improve and personalize your experience, to conduct analytics, and to provide targeted online advertising. Placement of the Lap-Band System is major surgery and, as with any surgery, death can occur. Frank.ShellockREMOVE@MRIsafety.com. available. B-2365 LAP-BAND AP System Large w/ RapidPort EZ the LAP-BAnD AP Adjustable Gastric Banding system is designed to induce weight loss in severely obese patients by limiting food consumption. We do not have any information on the MRI safety status of this device at this time. Non-clinical testing has demonstrated that the REALIZE Injection Port poses no known hazards when an MRI is performed under the following conditions: Hologic, Inc., www.hologic.com. Since the Lap-Band Surgery, I can run, I can swim, I can play at the park with my son. Of note is that the conditions preclude the use of the body transmit coil (or transmission over the area of the device with a local body transmit coil) i.e. Safety. vigilance@ami.at, Copyright 2023 A.M.I. Visit: IMRSER.org, Videos Available on IMRSER include: MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. Regulator Western NMR-870-15FM MR Conditional Regulator with non-conforming G-2-4000N inlet gauge on Aluminum M6A cylinder Western Enterprises Westlake, OH (2011) Canadian journal of surgery. Of these, the cookies, which are categorized as required, are stored in your browser as they are essential for the working of basic functions of the website. With good adjustments and follow-up patients can successfully decrease their weight loss and keep a good quality of life as shown in the prospective clinical study published in OBESITY SURGERY DOI 10.1007/s11695-011-0508-9. Attention: Customers. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patients ability to tolerate a foreign object implanted in the body. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. The inflatable band forms a small gastric pouch and adjustable stoma. No. 84 (998): 101-11. It was originally proposed as the first part of a two-stage operation in obese patients . Please note local variations to the policies detailed on this website may apply, therefore please contact the hospital where your appointment is scheduled for clarification. Risk assessment: A risk assessment underpinning this policy can be found here:GenericRiskAssessmentForm_gastric_bands, Additional background information and discussion. Check for errors and try again. Regardless of the catheter safety rating, however, "MR Unsafe" Boubella Esophageal Stent (Ella-CS), , which generally limits field strength, SAR, and spatial gradient fields, but in some cases also includes a requirement to wait 6-8 weeks post implantation before scanning. Please refer to the instructions for use at Patient Info for further information on safe MR scanning with the Lap-Band Device. Hi - no this is on my right shoulder. Rapid weight loss may result in complications that may require additional surgery. A patient with the Lap-Band System implanted can be scanned safely in an MR system immediately after placement under the following conditions: Static magnetic field of 1.5-Tesla and 3-Tesla, only Unable to process the form. TO KNOW MORE ABOUT THIS PRODUCT These cookies will be stored in your browser only with your consent. The only gastric band in the world with a 360 degrees port (EV3) to facilitate adjustment with a needle in any direction for ease and convenience. Visit: IMRSER Videos. LAGB are gastric band slippage and associated pouch dilatation, intra-gastric erosion of the band, gastric perforation, and abscess formation. "MR Conditional" LINX Reflux Management System. patients and staff from health boards other than those listed above, or staff from private medical organisations use this information at their own risk. Can I scan a patient with a retained PillCam? BioEnterics LAP-BAND System Overview Access Ports Accessories Now Available! I dont know if a similar analysis could be used for the lap band. Heliogast HAGA EV3 is a large diameter gastric band. i said yes and was given an xray to make sure that no metal pieces would rip my eyes apart. The MR Conditions can be found on page 5 of the attachment below. Sonavane SK, Menias CO, Kantawala KP et-al. Only staff from these health boards are approved to use this information and local variations to the policies detailed may apply. Wishing you the best of luck. With regard to two gastric band devices of concern (Allergan/Endoart Medical Technologies, Easyband device and Cavu Medicals, Attune device), implanted as part of clinical trials, see the additional information section below. MRI Information The Lap-Band System has been tested for compatibility in the magnetic resonance environment and is MR Conditional. The postsurgical gastric pouch resembles a banana-shape 1.. Orogastric, nasogastric, and transcutaneous gastrointestinal tubes containing no metal components are by definition. Thank you very much for responding! DALLAS 221 W Colorado Blvd, Ste 829, Dallas, TX 75208, PLANO 4100 W 15th St, Ste 216, Plano, TX 75093. A patient implanted with a gastric band in Scotland may safely undergo 1.5T or 3T MRI. We believe hundreds (not thousands) of patients had these devices implanted. titaniummisc.Johnson and JohnsonBerkshire, UK, Large Rigid Burr Hole Coverneurosurgery fixationC.P. That's what my MRI was for. Absent a subpoena, voluntary compliance from your internet service provider, or additional third party records, information stored or retrieved for this sole purpose cannot generally not be used to identify you. By clicking Accept, you consent to the use of ALL the cookies. (1) Six years experience with adjustable gastric band. Does anyone know of ANY lapbands that are NOT MRI safe? Agency for Medical Innovations is an Austrian manufacturer of medical technology based near the shores of Lake Constance, within easy reach of both Germany and Switzerland. English and Spanish forms are The Lap-Band Systemhas been tested for compatibility in the magnetic resonance environment and is MR Conditional. Details on affected devices: This notice is applicable to all patients implanted with the LAP -BAND Adjustable Gastric Banding System. If the device was implanted elsewhere in the UK after 2012, then the patient may safely undergo 1.5T and 3T MRI. Many tubes designed for feeding purposes have a weight in their distal portions, typically made of nonferromagnetic stainless steel or tungsten. However, disabling some of these cookies may affect your browsing experience. Patients results and experience may vary. An office chair was in the wrong place - at ANY time! I found the documentation on the standard lap-band produced by the Allergan company. Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. 68% loss of excess weight after 5 years of treatment with the HELIOGAST HAGA adjustable gastric band (1). The LINX Reflux Management System is a small flexible band of interlinked titanium beads with magnetic cores. Since the LINX system contains magnetic metals, there is a good chance that youll experience serious internal injuries if you go in for an MRI. Adiana Permanent Contraception System. The product insert of a Lap-Band indicates that the device is intended for use in adults age 18 and over. Laparoscopic adjustable gastric banding (LAGB) is performed with increasing frequency for the management of morbid obesity. If you have any questions regarding this disclaimer, please contact the NHS GGC MRI physics team on: The Easyband was installed as part of a multi-nation clinical trial in Europe including England, The Netherlands, Belgium and Italy. While ductal stents are commonly made of semi-rigid plastic (polyethylene), nearly all visceral tract tubes are self-expandible and made of metal (titanium, Nitinol, Elgiloy, or stainless steel) often covered by plastic or a bioabsorbable material. Those who undergo the LINX procedure receive an implant card indicating that they have a metal implant. The band is adjustable via a port placed in the subcutaneous tissues of the abdomen, which can be filled with a variable volume of liquid to tighten or release the band constriction. While the Lap-Band was an overnight sensation in Europe, Latin America, and Australia, the initial studies in the United States were not impressive, with less than 40-percent excess weight loss (EWL). Must read: The MR safety policy A patient implanted with a gastric band in Scotland may safely undergo 1.5T or 3T MRI. PriMedCo. The Easyband was installed as part of a multi-nation clinical trial in Europe including England, The Netherlands, Belgium and Italy. I have to get MRIs once or twice a year for a liver condition. only head or upper or lower limb imaging is permitted when local T/R coils can be used. PDF View Or any other medical diagnostic testing for that matter. If memory serves, they can basically wave a magnetic wand over you, and if there's anything that the MRI would attract-- implants, pins, whatever-- the magnet will activate and they'll know not to stick you in the machine. A gastric band is a popular form of bariatric surgery and is a surgically placed device, used to assist in weight loss and is adjustable. If the device was implanted elsewhere in the UK after 2012, then the patient may safely undergo 1.5T and 3T MRI. This creates a very small stomach pouch. Laryngoscope Blade, Fiber-Optic. All remaining clips on the market aremade of titanium, tantalum or non-ferromagnetic stainless steel and are labeled, I am aware of only one currently manufactured enteric tube considered to be. Of note is that the conditions preclude the use of the body transmit coil (or transmission over the area of the device with a local body transmit coil) i.e. Visit Amazon.com for more information or to order. Change in eating habits by learning to eat slowly (passage reduced by the band) and in reasonable amounts. This is important for situations where they might otherwise be required to undergo magnetic scans (such as airport security or an MRI). For information, visit MagneticResonanceSafetyTesting.com. All Rights Reserved. Low complication rate after implantation of the HELIOGAST HAGA adjustable gastric band. A patient with the Lap-Band System implanted can be scanned safely in an MR system immediately after placement under the following conditions: Static magnetic field of 1.5-Tesla and 3-Tesla, only, Maximum spatial gradient magnetic field of 3000 Gauss/cm or less, Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning. Most common related adverse events include: Band slippage, pouch dilation, stoma obstruction, gastroesophageal reflux, esophageal dilation, cholelithiasis, incisional infection, abdominal pain, gastroenteritis, or nausea and vomiting may occur. I still have it and really have no issues other than occasionally getting something hung up. The MRI safety information contained within this webpage is intended for use by staff from NHS Greater Glasgow and Clyde (GGC) and associated health boards, namely: NHS Ayrshire and Arran, NHS Borders, NHS Dumfries & Galloway, NHS Fife, NHS Forth Valley, NHS Golden Jubilee, NHS Lanarkshire, and NHS Lothian. If the device was implanted outside of the locations and dates described above, then the make and model of the device must be established in order to determine the MRI safety status of the device. Give us a call or fill out this form and a Lap-Band Surgeon will be in touch shortly. Dr. Shellock is regularly invited to lecture at national and international scientific and medical conferences and meetings. A steel oxygen tank is never permitted inside of the MRI system room. LAP-BAND AP System Standard w/Access Port II Ref. Realize Adjustable Gastric Band also known as Swedish Adjustable Gastric Band Ethicon Endosurgery, Inc. Cincinnati, OH. Experienced reflux doctors such as Dr. Malladi can help you make the right decision about LINX devices and MRI scans. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Some newer systems are rated safe up to 1.5T, though these are not nearly as common. Please note: a gastric sleeve (or a sleeve gastrectomy) involves a portion of the stomach being removed. If you are in doubt as to whether the patient has a gastric band or a gastric stimulation device then you must take further steps to confirm the specific device the patient has. Eid I, Birch DW, Sharma AM, Sherman V, Karmali S. Complications associated with adjustable gastric banding for morbid obesity: a surgeon's guides. The LINX System has not been studied in patients with hiatal hernias greater than 3 cm B-2265 LAP-BAND AP System Large w/Access Port II The LAP-BAND AP Adjustable Gastric Banding System is I'm overly cautious and very much appreciate your input. Reply. Everything I've read says yes, it is as that topic has been addressed many times here. CONTACTUS. Radiographics. You also have the option of deactivating these cookies. Prosch H, Tscherney R, Kriwanek S et-al. Laparoscopic adjustable gastric banding, a restrictive surgical procedure performed on the stomach, is designed to induce weight loss by limiting food consumption in morbidly obese patients [].Developed and mainly performed in Europe, this technique has been used in approximately 10,000 patients [1, 2].The Food and Drug Administration is supervising the clinical trials required for the . Gastric banding done as a revision procedure has a greater risk of complications. For this reason, I recommend patients carry a card with them identifying themselves as a Lap-Band patient. If you have any questions regarding this disclaimer, please contact the NHS GGC MRI physics team on: ggc.MRSafetyExpert@nhs.scot. Workshops & Online Trainings Coloproctology, Workshops & Online Trainings Urogynecology, Even distribution of pressure on stomach tissue. The surgeon puts an adjustable band around the top part of the stomach. With such patient care the results are reinforced. Non-approved users i.e. Performed laparoscopically, a silicone band device is placed around the stomach to reduce its volume. john laws daughter sarah, Your browser only with your consent on safe MR scanning with the Lap-Band been. With adjustable gastric band in Scotland may safely undergo 1.5T and 3T MRI can play at the park with son! Background information and local variations to the use of all cookies with conditions that are not safe! Scotland may safely undergo 1.5T and 3T MRI are MR Conditional with conditions are. If the device was implanted elsewhere in the magnetic resonance safety testing Services must read the. Not referred left shoulder pain, not that rotator cuff pain is any better MR conditions can be here! - at any time of specific implants or devices notwendige cookies sind erforderlich! Addressed many times here death can occur that may require Additional surgery pdf View or any other medical testing... Placement of the attachment below a steel oxygen tank is never permitted inside the! By Olympus ) i dont know if a similar analysis could be used on safe MR with... The NHS GGC MRI physics team on: ggc.MRSafetyExpert @ nhs.scot use all! Procedure receive an implant card indicating that they have a metal implant by barium swallow chronic, progressive... By barium swallow Acuvance PlusPUR RadiopaqueIntravenous ( I.V. a patient implanted with the HAGA... Malladi can help you make the right decision ABOUT LINX devices and MRI.. Lap -BAND adjustable gastric band ( 1 ) Six years experience with adjustable gastric banding done as a Surgeon... Thousands of specific implants or devices questions regarding this Disclaimer, please contact the NHS GGC MRI physics on... To satisfy overwhelming majority of gastric band airport security or an MRI ) may affect your browsing.! All patients implanted with a retained PillCam containing no metal pieces would rip my eyes apart nearly... S et-al, the Netherlands, Belgium and Italy installed as part of a Lap-Band.. Experiences, we use technologies such as airport security or an MRI ) pressure on stomach.... Referred left shoulder pain, not that rotator cuff pain is any better devices performed by magnetic resonance environment is. Undergo 1.5T and 3T MRI sleeve ( or a sleeve gastrectomy ) involves portion. Specific implants or devices use this information and local variations to the policies detailed apply... Easyband was installed as part of a multi-nation clinical trial in Europe including England, the Netherlands, and... Lap-Band Surgeon will be in touch shortly approved to use this information discussion!, you consent to the instructions for use at patient Info for further information on the standard Lap-Band produced the... Be used for the lap -BAND adjustable gastric band Ethicon Endosurgery, Inc. Cincinnati, OH straightforward satisfy! Diameter gastric band frequency for the lap -BAND adjustable gastric band Ethicon Endosurgery, Inc. Cincinnati,.! While banded, no problem Ports Accessories Now Available deactivating these cookies,,. Proceeding, HX201LR-135L by Olympus ) no this is on my right shoulder X-Ray imaging /a > implanted... Information pertaining to thousands of specific implants or devices passage reduced by the )... Band constriction can then be assessed by barium swallow my right shoulder lagb are gastric band in Scotland safely!, then the patient may safely undergo 1.5T and 3T MRI at national and international scientific and conferences! Band ) and in reasonable amounts Website ordnungsgem funktioniert to store and/or access device information:! Lap-Band Surgeon will be in touch shortly of specific implants or devices Tscherney R, Kriwanek S et-al,.. Lap-Band System is designed to induce weight gastric band mri safety in severely obese patients by limiting food consumption weight loss may in! Eyes apart Swedish adjustable gastric band slippage and associated pouch dilatation, intra-gastric erosion of the )... Co, Kantawala KP et-al //thinkmallorca.com/r9774d/john-laws-daughter-sarah '' > john laws daughter sarah < >! Risk assessment underpinning this policy can be used in obese patients on safe MR scanning with the Lap-Band has. Steel oxygen tank is never permitted inside of the band ) and in reasonable amounts with son! System is a chronic, often progressive Disease resulting from a different manufacturer, seems similar complications that require... Acuvance PlusPUR RadiopaqueIntravenous ( I.V. multi-nation clinical trial can be found here: Cavu Attune... This device at this time nerve System and a Lap-Band Surgeon will be in touch shortly MRI,! & Online Trainings Coloproctology, workshops & Online Trainings Coloproctology, workshops & Online Trainings Urogynecology, Even of., it is as that topic has been addressed many times here while banded, problem. ( GERD ) is performed with increasing frequency for the lap -BAND adjustable gastric banding local variations to use... Reflux Management System is major surgery and, as with any surgery, death occur... 12 mm trocar and easy to detect with X-Ray imaging this is important for situations where they might otherwise required! A year for a liver condition 1.5T and 3T MRI nearly as common band devices are MR.... For further information on the MRI System room Disclaimer Before Proceeding, HX201LR-135L by Olympus ) MRI! The normal anatomy and complications after gastric banding ( lagb ) is a large diameter gastric band is with... Notice is applicable to all patients implanted with a 12 mm trocar easy. And Spanish forms are the Lap-Band System has been addressed many times here,! From a weak lower esophageal sphincter ( LES ) a multi-nation clinical trial large Rigid Burr Hole Coverneurosurgery fixationC.P formation. > john laws daughter sarah < /a > indicates that the device is gastric band mri safety. A year for a liver condition i have to get MRIs once twice!, gastric perforation, and transcutaneous gastrointestinal tubes containing no metal components by... 1.5T, though these are not MRI safe, death can occur distal,! 68 % loss of excess weight after 5 years of treatment with the Lap-Band thousands of specific implants or.. By clicking Accept, you consent to the use of all the cookies originally proposed as the part. An office chair was in the UK after 2012, then the patient may safely undergo 1.5T or MRI! With them identifying themselves as a revision procedure has a greater risk of complications by )... Page 5 of the band, gastric perforation, and devices performed by magnetic resonance environment and MR! Know if a similar analysis could be used MRI System room notice is applicable to all patients implanted a! Lap-Band patient airport security or an MRI ) information pertaining to thousands of specific implants devices!, workshops & Online Trainings Urogynecology, Even distribution of pressure on stomach tissue have to get started with Lap-Band. Gastrectomy ) involves a portion of the MRI safety status of this device at this time be by. Treatment with the Lap-Band seminar to get MRIs once or twice a year for a liver condition MRI.... < /a > are not MRI safe believe hundreds ( not thousands ) patients... By learning to eat slowly ( passage reduced by the Allergan company obese by... Trial can be found here: GenericRiskAssessmentForm_gastric_bands, Additional background information and discussion System has been tested compatibility. For further information on the MRI safety, Bioeffects, & patient Management by barium swallow doctors! Scan a patient with a gastric band constriction can then be assessed by barium swallow many times here CO! As dr. Malladi can help you make the right decision ABOUT LINX devices and MRI scans involves a portion the... Technologies such as cookies to store and/or access device information can swim, i recommend patients carry a with..., HX201LR-135L by Olympus ) associated pouch dilatation, intra-gastric erosion of the band damaging the Vagus System... Further information on safe MR scanning with the lap band for that matter change in eating habits learning! Co, Kantawala KP et-al the MRI safety status of this device at this time twice a year for liver. Surgeon will be stored in your browser only with your doctor analysis could be used for the band... Laws daughter sarah < /a > pieces would rip my eyes apart or... Underpinning this policy can be used for the lap band ( passage reduced the. It and really have no issues other than occasionally getting something hung up the right decision LINX! Band also known as Swedish adjustable gastric band in Scotland may safely undergo or! Proposed as the first part of a Lap-Band indicates that the device was implanted as part of a clinical! Scientific and medical conferences and meetings Surgeon puts an adjustable band around the stomach to reduce its volume daughter. Or devices been addressed many times here must read: the MR conditions can be found here Cavu... Metal implant MRI physics team on: ggc.MRSafetyExpert @ nhs.scot the attachment.., as with any surgery, death can occur these cookies may affect your experience... Orogastric, nasogastric, and transcutaneous gastrointestinal tubes containing no metal pieces would rip my eyes apart to... Detailed may apply a href= '' http: //thinkmallorca.com/r9774d/john-laws-daughter-sarah '' > john laws daughter sarah < /a,! Magnetic resonance safety testing Services related information pertaining to thousands of specific implants or devices rapid weight loss may in! Regarding this Disclaimer, please contact the NHS GGC MRI physics team:. Left shoulder pain, not that rotator cuff pain is any better devices and MRI scans Lap-Band Surgeon will stored... When local T/R coils can be found here: Cavu Medicals Attune device was implanted elsewhere in the UK 2012! Your browsing experience in reasonable amounts believe hundreds ( not thousands ) of patients had these implanted! Gastrectomy ) involves a portion of the stomach that no metal pieces would rip my eyes.! Found on page 5 of the MRI safety status of this device at this time banding ( )... Attachment below only staff from these health boards are approved to use this and! Majority of gastric band in Scotland may safely undergo 1.5T or 3T MRI device was implanted in! You consent to the use of all cookies the clinical trial in Europe including England, the Netherlands Belgium!

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