EICHORCondition: Obesity · Sponsor: Boston Scientific Corporation
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Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ 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.
This description comes directly from the study's public registry record.
Shay Caravaggio · (508) 683-4000 · shay.caravaggio@bsci.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: 1. Subject is ≥ 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 Orbera365™ 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 ≤ 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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| OB Klinika | Prague, Czechia | Recruiting |
| Hôpital Avicenne | Bobigny, France | Not Yet Recruiting |
| EndoBes - Centre Medico Teknon | Barcelona, Spain | Recruiting |
| Dorsia Clinic, Madrid Spain | Madrid, Spain | Recruiting |
| UHCW NHS Trust | Coventry, West Midlands, United Kingdom | Not Yet Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT07062094