Orbera365 intragastric balloon for weight loss and safety during up to 12 months in place

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter registry in the European Union collects standard-of-care data from adults who have already agreed to receive the Orbera365 intragastric balloon for weight loss. Up to 200 subjects (minimum 100) will be enrolled at up to ten sites, with visits during the device in-dwell period and a single 30-day post-removal follow-up; total participation lasts up to 13 months. The registry is intended to document safety outcomes and routine weight-management measures for extended in situ dwell time of 6 to 12 months. Data are obtained from regular clinical visits without additional experimental procedures beyond usual care.

Why it matters

Who can join: the full rules

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

Where it's running

• OB Klinika
  Prague, Czechia 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

Study contacts

• Study coordinator: Shay Caravaggio
• Email: shay.caravaggio@bsci.com
• Phone: (508) 683-4000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.