iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
Trial Parameters
Brief 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.
Eligibility Criteria
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 mell