Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obes… (NCT03900481) | Clinical Trial Compass
TerminatedNot Applicable
Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity
Stopped: Premature end of inclusion
France29 participantsStarted 2019-09-17
Plain-language summary
The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)\>25%. The secondary objectives are to measure total body weight loss \>5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice
Who can participate
Age range
18 Years – 65 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:
* 18 years ≤ age ≤ 65 years
* Class I obesity (30 \<BMI \<35 kg / m²) or Class II without comorbidity (35 \<BMI \<40 kg / m²)
Exclusion Criteria:
* Achalasia or other disturbance of motility of the esophagus;
* severe esophagitis;
* Peptic ulcer disease;\* uncontrolled diabetes
* Weight loss\> 5% of the total weight over the last 6 months;
* Gastrointestinal stenosis or obstruction;
* Pregnancy, breastfeeding, or desire for pregnancy in the next 18 months;
* Previous bariatric surgery, balloon or other endoscopic therapy of obesity;
* Gastric surgery scheduled within 60 days of 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.