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OverStitch NXT Endoscopic Suture System | Clinical Trials | Clareo Health

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OverStitch NXT Endoscopic Suture System

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

NCT07276815•Boston Scientific Corporation

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older, or subjects who have reached the legal age for signing informed consent in accordance with local laws and regulations.
•2. BMI ≥ 32.5 kg/m²; or BMI ≥ 27.5 kg/m² combined with type 2 diabetes mellitus (regardless of the effectiveness of medical treatment for type 2 diabetes); or BMI between 27.5 kg/m² and 32.5 kg/m² with ineffective medical weight loss or combined with other obesity-related diseases for which medical treatment is ineffective.
•3. Willing to comply with the long-term strict dietary restrictions required by the surgery.
•4. Capable of providing informed consent, able to complete all routine follow-up visits, and willing to abide by the protocol requirements, including signing the informed consent form, completing relevant examinations, and receiving dietary counseling.
•5. Females of childbearing potential (i.e., premenopausal or not sterilized) must agree to use adequate contraceptive measures.

Exclusion Criteria

•1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
•2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
•3. Prior open or laparoscopic bariatric surgery.
•4. Prior surgery of any kind on the esophagus or any type of hiatal hernia surgery.
•5. Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, specific inflammation such as Crohn's disease, and the doctor judges that it may affect the operation or efficacy of ESG.
•6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenosis.
•7. History of gastrointestinal stromal tumors, gastrointestinal cancer, low-grade or high-grade gastric intraepithelial neoplasia, or familial or non-familial adenomatous polyposis syndrome.
•8. Gastric masses or untreated gastric polyps with a diameter \> 1 cm.
•9. Hiatal hernia (Z-line displacement above the diaphragm \> 4 cm) or severe/refractory gastroesophageal reflux symptoms, which the physician judges may affect the performance or prognosis of ESG.
•10. Structural abnormalities of the esophagus or pharynx that may impede endoscopic passage (e.g., strictures or diverticula), which the physician judges may affect the performance or prognosis of ESG.
+20 more criteria

Key Dates

Start Date

July 31, 2026

Primary Completion Date

October 31, 2028

Completion Date

October 31, 2029

Last Updated

February 13, 2026

Enrollment

136

ESTIMATED participants

Conditions

Weight Loss

Interventions

OverStitch NXT Endoscopic Suture System

DEVICE

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OverStitch NXT Endoscopic Suture System

Inclusion Criteria

Exclusion Criteria

Protein Supplementation Intervention on Body Weight

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Dyad Plus Effectiveness/Feasibility

Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults