Safety and Effectiveness of Orbera365™ Intragastric Balloon System

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.

NCT Number	NCT07062094
Lead Sponsor	Boston Scientific Corporation
Conditions	Obesity
Enrollment	200 participants
Start Date	2026-04-07
Primary Completion	2028-04-07 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-13