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RECRUITING
NCT07062094

Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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

DEVICE

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