iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
China216 participantsStarted 2026-03-01
Plain-language summary
Obesity and overweight are rising in Chinese populations, where metabolic risks begin at lower BMI thresholds than in Western cohorts. Many individuals with overweight or mild-to-moderate obesity are ineligible or unwilling to undergo bariatric surgery due to invasiveness and risk. Endoscopic bariatric and metabolic therapies offer minimally invasive alternatives but vary in complexity, cost, and safety profiles. Investigators developed a sutureless endoscopic procedure, Endoscopic Radial Compression Gastroplasty (ERCG), which reduces gastric volume by apposing gastric walls using a clip-and-loop system. This randomized controlled trial evaluates the efficacy and safety of ERCG versus an optimized lifestyle intervention in Asian adults with BMI 24.0-37.4 kg/m² who have not succeeded with conservative measures. Preliminary studies suggest ERCG can achieve approximately 12% total body weight loss (TBWL) at 3 months. The primary endpoint is percent TBWL at 3 months; secondary outcomes include changes in BMI, metabolic parameters, quality of life, and adverse events. Results are expected to inform the role of ERCG as a safe, effective, and scalable option between conservative care and bariatric surgery.
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:
* Asian adults aged 18-65 years.
* BMI 24.0-37.4kg/m²(Chinese standard)。
* Failed prior conservative weight loss attempts ≥2 months。
* Willingness to comply with follow-up.
* Provided written informed consent.
Exclusion Criteria:
* Prior gastrointestinal surgery with clinically relevant sequelae.
* Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric/duodenal ulcer), or neoplastic lesions.
* Any condition associated with an increased risk of upper gastrointestinal bleeding.
* Hiatal hernia \>2 cm or severe/refractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.
* Esophageal/pharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).
* Achalasia or other severe esophageal motility disorder.
* Severe coagulopathy.
* Insulin-dependent diabetes mellitus.
* Chronic abdominal pain.
* Gastrointestinal motility disorder (e.g., gastroparesis).
* Hepatic impairment or cirrhosis.
* Severe or uncontrolled psychiatric illness.
* Alcohol abuse or substance dependence.
* Unwilling to participate in a physician-supervised diet/behavior modification program and/or unwilling to comply with routine follow-up.
* Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.
* Unable or unwilling to take proton pump inhibitor (PPI…
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.