OverStitch NXT Endoscopic Suture System
ConditionWeight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
OverStitch NXT Endoscopic Suture System
DeviceThe OverStitch NXT Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor sutures can be placed for endoscopic sleeve gastroplasty（ESG）.
Treatment groups
136 Participants
are divided into 3 treatment groupsGroup A: Roll-in CasesOther 1 intervention
Group B: Treatment groupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
%TBWL (Defined as the percentage of total body weight loss)
%TBWL is defined as the percentage of total body weight loss
Time frame
At 12 months after the intervention.2
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%
Time frame
At 12 months after the interventionSponsors and contacts
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Source ClinicalTrials.gov