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Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Sponsor: Boston Scientific Corporation
Summary
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.
Official title: Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-04
Completion Date
2028-05-01
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Intragastric Balloon
The Orbera365™ IGB System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance. The IGB is placed in the stomach and filled with sterile saline, causing it to expand into a spherical shape. The filled IGB is designed to occupy space and move freely within the stomach, potentially altering appetite and satiety to achieve weight loss.
Locations (5)
OB Klinika
Prague, Czechia
Hôpital Avicenne
Bobigny, France
EndoBes - Centre Medico Teknon
Barcelona, Spain
Dorsia Clinic, Madrid Spain
Madrid, Spain
UHCW NHS Trust
Coventry, West Midlands, United Kingdom