NCT07276815

OverStitch NXT Endoscopic Suture System

Gathering of Results in Eligible Asian Obese Populations About Safety and Effectiveness of Overstitch ESG Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.

Detailed description

The study is a prospective, multicenter, randomized controlled trial This study is planned to be conducted at 10 sites, with each center initially enrolling 2 roll-in cases (totaling 20 cases). After each site completes the enrollment of its roll-in cases, the remaining subjects will be randomly divided into two groups (the treatment group and the control group) via a central randomization system. Each group will ultimately enroll 58 subjects, resulting in a total sample size of 136 for the study. Roll-in Cases: ESG combined with lifestyle management for 12 months. treatment group: ESG combined with lifestyle management for 12 months. control group: Lifestyle management alone for 12 months, followed by evaluation. Eligible participants may undergo ESG afterward.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DEVICE	OverStitch NXT Endoscopic Suture System	The OverStitch NXT Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor sutures can be placed for endoscopic sleeve gastroplasty（ESG）.

Timeline

• Start date: 2026-07-31
• Primary completion: 2028-10-31
• Completion: 2029-10-31
• First posted: 2025-12-11
• Last updated: 2026-03-24