Records outcomes of an intragastric balloon for weight loss in adults with obesity
Follows adults with obesity who receive a stomach balloon for weight loss.
Plain-language title generated from the registry record
Registry title: Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Key facts
- Where
- Barcelona and Madrid, SpainSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity in the EU who have already agreed to get the Orbera365 stomach balloon for weight loss.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Obesity with a BMI of 30-50 kg/m2 for weight loss, or a BMI of 40 kg/m2 and above, or a BMI of 35 kg/m2 with other health conditions, before obesity or another surgery, as the device instructions allow.
- Earlier treatment
- No weight loss supplements or medicines in the 3 months before the first visit. No earlier surgery on the esophagus, stomach or duodenum, and no weight loss (bariatric) surgery.
Main reasons for not taking part
- Planning to become pregnant in the year after the balloon is placed
- Unable or unwilling to take the prescribed proton pump inhibitor medicine while the balloon is in place
- Planning follow-up visits at a place where the treating doctor does not practice
- Conditions that rule out the Orbera365 balloon, such as stomach or bowel inflammation, ulcers, a stomach mass or a severe motility disorder
- Taking aspirin, anti-inflammatory drugs or blood thinners without medical supervision
Read by machine on 12 November 2026.
Where in Spain
- EndoBes - Centre Medico TeknonBarcelona, SpainContact: Román Turró Arau, MDTaking people
- Dorsia Clinic, Madrid SpainMadrid, SpainContact: Elena AlcobaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Boston Scientific Corporation
- Trial code
- NCT07062094
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry
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.
Inclusion: 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.
Exclusion: 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; 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.