Not Yet RecruitingNot Applicable

OverStitch NXT Endoscopic Suture System

136 participantsStarted 2026-07-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged 18 years or older, or subjects who have reached the legal age for signing informed consent in accordance with local laws and regulations.
✓. 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.
✓. Willing to comply with the long-term strict dietary restrictions required by the surgery.
✓. 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.
✓. Females of childbearing potential (i.e., premenopausal or not sterilized) must agree to use adequate contraceptive measures.

Exclusion criteria

✕. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
✕. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
✕. Prior open or laparoscopic bariatric surgery.
✕. Prior surgery of any kind on the esophagus or any type of hiatal hernia surgery.
✕. 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.
✕. 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.
✕. History of gastrointestinal stromal tumors, gastrointestinal cancer, low-grade or high-grade gastric intraepithelial neoplasia, or familial or non-familial adenomatous polyposis syndrome.
✕. Gastric masses or untreated gastric polyps with a diameter \> 1 cm.

What they're measuring

%TBWL (Defined as the percentage of total body weight loss)

Timeframe: At 12 months after the intervention.

The response rate at the 12th month after the intervention

Timeframe: At 12 months after the intervention

Trial details

NCT IDNCT07276815

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-31

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