OverStitch NXT Endoscopic Suture System

NCT07276815 | Not Yet Recruiting

• 1 other identifier: E7241
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

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

  %TBWL is defined as the percentage of total body weight loss

  At 12 months after the intervention.

• The response rate at the 12th month after the intervention

  Response is defined as having a percentage of total body weight loss (%TBWL) of ≥ 5%

  At 12 months after the intervention

Study Arms (3)

Roll-in Cases

OTHER

ESG combined with lifestyle management for 12 months

Device: OverStitch NXT Endoscopic Suture System

Treatment group

EXPERIMENTAL

ESG combined with lifestyle management for 12 months.

Device: OverStitch NXT Endoscopic Suture System

Control group

NO INTERVENTION

Lifestyle management alone for 12 months, followed by evaluation. Eligible participants may undergo ESG afterward.

Interventions

OverStitch NXT Endoscopic Suture System DEVICE

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）.

Roll-in Cases; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Gastrointestinal motility disorders (e.g., achalasia, severe esophageal motility disorders, gastroparesis, or intractable constipation), which the physician judges may affect the performance or prognosis of ESG.
• Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia nervosa.
• Coagulopathy with INR \> 1.5 that cannot be corrected (per physician's judgment) or requirement for continuous full anticoagulant therapy, and/or any underlying diseases associated with high bleeding risk.
• Insulin-dependent diabetes mellitus (type 1 or type 2), or high likelihood of requiring insulin therapy within the next 12 months.
• Decompensated cirrhosis, or acute/chronic liver dysfunction that the physician judges make the subject unsuitable for ESG treatment.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04