Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss (NCT06894498) | Clinical Trial Compass
TerminatedNot Applicable
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Stopped: Business decision.
United States2 participantsStarted 2026-03-31
Plain-language summary
The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.
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:
* Subject is ≥ 18 years of age at the time of the ESG procedure
* Subject with a BMI between 30 kg/m2 and 50 kg/m2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System
* Subject completed follow-up 1-year from the ESG procedure for weight loss management
* Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)
* Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.
* Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)
* Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study
Exclusion Criteria:
* None
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.
1This trial was terminated before completing — does that mean the five-year safety and effectiveness data for endoscopic sleeve gastroplasty was never fully collected, and how does that gap affect what we know about long-term outcomes?
2Since this study was specifically looking at whether weight loss from ESG holds up at five years, what does the currently available evidence say about long-term weight maintenance after this procedure, given that the trial didn't finish?
3Given that this trial has been terminated, are there other active studies or published data on ESG's long-term results that I should be aware of before deciding whether this procedure is right for me?
4Compared to ESG, would a more established weight-loss approach — like bariatric surgery or a medically supervised program — have stronger long-term outcome data that might make it a safer choice for my situation?
5Because this trial is no longer enrolling and was terminated early, is ESG still considered a viable option for me, or does the incomplete research make my doctor hesitant to recommend it?
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
Proportion of subjects that maintain clinically significant weightloss at five-year visit