NCT07062094Recruiting
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- 7 Apr 2026
- Primary completion date
- 7 Apr 2028
- Lead sponsor
- Boston Scientific Corporation
- Diseases
- Obesity
- NCT number
- NCT07062094
What you commit to
- Study type: Observational
- Planned participants: 200
- From 7 Apr 2026 to the primary completion date, 7 Apr 2028
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
- 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
Other
- Subject is planning on becoming pregnant during the one year following study device placement
- Subject will complete follow-up visits at a location that the treating physician does not practice
Who the study is looking for
- Subject is ≥ 18 years of age
- 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.
- Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OB Klinika Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| EndoBes - Centre Medico Teknon Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Dorsia Clinic, Madrid Spain Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| UHCW NHS Trust Coordinator of this site? Confirm its status | Coventry | United Kingdom | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.