Recruiting
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry
- Sponsor
- Boston Scientific Corporation (Industry)
- Enrolment
- 200 planned
- Conditions
- Obesity
- Interventions
- Intragastric Balloon
- Ages
- adults, older adults
- Registry
- NCT07062094
Full record on ClinicalTrials.gov
From the 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.
Primary outcomes
- Rate of Subjects with Serious Adverse Events
- Rate of Treatment Completers
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered