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Safety and Effectiveness of Orbera365™ Intragastric Balloon System

NCT07062094 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-05-20

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-07
Primary Completion
2028-04-07
Completion
2028-05-01

Countries

  • Czechia
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062094 on ClinicalTrials.gov