OverStitch NXT Endoscopic Suture System (NCT07276815) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
%TBWL (Defined as the percentage of total body weight loss)
Timeframe: At 12 months after the intervention.
2
The response rate at the 12th month after the intervention
. 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.