NCT07062094

Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study's objective is to confirm the safety of the Orbera365™ Intragastric Balloon (IGB) for extended in situ dwell time (from 6 months up to 12 months). This information can be collected from standard-of-care data. Up to ten (10) sites located in Europe are planned to participate in this registry. A minimum of 100 subjects are required for the registry. A maximum of 200 subjects may be enrolled into the registry. The study population will include Obese patients ((Body Mass Index (BMI) 30-50 kg/m2)) who have already consented to receive the Orbera365™ IGB System, who previously failed to achieve and maintain weight loss with a supervised weight-control program. Study subjects will also include obese and super obese patients (BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk. The duration of study participation is expected to be up to thirteen months from study placement procedure. The total treatment with the study device will be no more than 12 months from placement. A 30-day post-removal assessment will be performed following the study removal procedure. The subject will have completed the study upon the completion of the 30-day post-removal assessment, regardless of when the study removal procedure occurred.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-07
• Primary completion: 2028-04-07
• Completion: 2028-05-01
• First posted: 2025-07-14
• Last updated: 2026-04-14

Locations

5 sites across 4 countries: Czechia, France, Spain, United Kingdom