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

Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry

This registry will collect routine clinic data to see if the Orbera365 intragastric balloon is safe and helpful for adults with obesity (BMI 30–50, or higher with comorbidities) when left in place for up to 12 months.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (Industry-sponsored)
• Locations: 5 sites (Prague and 4 other locations)
• Trial ID: NCT07062094 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with BMI 30–50 kg/m2, or BMI ≥40 kg/m2 (or ≥35 kg/m2 with comorbidities) who have previously failed supervised weight-loss programs and who have already consented to receive the Orbera365 device are the intended participants.

Not a fit: Patients planning pregnancy, unable or unwilling to take proton pump inhibitors, currently using weight-loss medications/supplements within three months, or unable to complete follow-up at the treating physician’s location are unlikely to be eligible or receive benefit from this registry.

Why it matters

Potential benefit: If successful, the registry could support that leaving the Orbera365 balloon in place for up to 12 months is a safe, longer-duration non-surgical option to help patients lose weight.

How similar studies have performed: Previous intragastric balloon devices, including earlier Orbera systems used for shorter (~6-month) placements, have shown weight-loss benefits, but evidence for safety and outcomes with 12-month dwell time is more limited.

Eligibility criteria

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 this trial is running

Prague and 4 other locations

• OB Klinika — Prague, Czechia (Recruiting)
• Hôpital Avicenne — Bobigny, France (Not_yet_recruiting)
• EndoBes - Centre Medico Teknon — Barcelona, Spain (Not_yet_recruiting)
• Dorsia Clinic, Madrid Spain — Madrid, Spain (Not_yet_recruiting)
• UHCW NHS Trust — Coventry, West Midlands, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: Shay Caravaggio

Conditions Obesity; Orbera365; Intragastric Balloon; Orbera365™ IGB System