NCT07195708

Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')

Clinical Study to Evaluate the Safety and Efficacy of the Orbera365 Intragastric Balloon System in Obese Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.

Detailed description

The study is a prospective, multicenter, randomized controlled, non-blinded trial. The treatment group was the group with the placement of Orbera 365 plus lifestyle management, while the control group was the lifestyle management group. The central randomization system was adopted to randomly assign the research subjects into the experimental group and the control group. The subjects were enrolled at a 1:1 ratio, with 72 cases in each group, making a total of 144 cases. The subjects in the treatment group will be followed up until 6 months after the balloon removal or 12 months after the endoscopy procedure, whichever comes later. The control group is planned to receive a 12-month lifestyle intervention, and the maximum follow-up period is up to 18 months.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DEVICE	Treatment group	The treatment group was the group with the placement of Orbera 365 plus lifestyle management

Timeline

• Start date: 2026-05-30
• Primary completion: 2028-04-30
• Completion: 2028-10-31
• First posted: 2025-09-29
• Last updated: 2026-03-24