AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Safety and Effectiveness of Orbera365โ„ข Intragastric Balloon System

Recruitingn/aAges 18 Years - anyAllBoston Scientific Corporation
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365โ„ข Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Subject is โ‰ฅ 18 years of age 2. Subject meets the indicated population for the device according to the Instructions for Use (IFU) including obese patients with the BMI of 30-50 kg/m2 for weight loss and patients with BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities before obesity or another surgery, unless contraindicated. 3. Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry Exclusion Criteria: 1. Subject is planning on becoming pregnant during the one year following study device placement 2. Subject will complete follow-up visits at a location that the treating physician does not practice 3. Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant. 4. Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications. 5. Subjects who have conditions that are contraindicated for Orbera365โ„ข IGB System as per the IFU, including, but not limited to: * The presence of more than one IGB at the same time. * Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease * Potential upper gastrointestinal bleeding conditions * A large hiatal hernia of \> 5cm or a hernia โ‰ค 5 cm associated with severe or intractable gastro- esophageal reflux symptoms * A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope * Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device. * Gastric Mass. * Severe coagulopathy. * Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision. * Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery
๐Ÿ’Š

What it tests

  • Intragastric Balloon
๐Ÿ“

Where

4 sites
OB Klinika
Prague, Czechia
EndoBes - Centre Medico Teknon
Barcelona, Spain
Dorsia Clinic, Madrid Spain
Madrid, Spain
UHCW NHS Trust
Coventry, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy