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RECRUITING

NCT07237750

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

Sponsor: Liu Yan

View on ClinicalTrials.gov

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.

Official title: iWAIST Trial: A Multicenter, Single-Blind, Randomized, Sham-Controlled Trial of Endoscopic Radial Compression Gastroplasty (ERCG) Plus Optimized Lifestyle Intervention for Weight Management in Chinese Adults With Overweight or Mild-to-Moderate Obesity

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-03-01

Completion Date

2027-05-31

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Overweight and/or Obesity Metabolic Syndrome Nonalcoholic Fatty Liver Disease Chinese

Interventions

PROCEDURE

Endoscopic Radial Compression Gastroplasty

Sutureless endoscopic gastric volume reduction using a novel clip-and-endoloop apposition system; performed under general anesthesia or deep sedation; standard perioperative care.

BEHAVIORAL

Optimized Lifestyle Intervention (OLI)

Structured nutrition counseling, calorie deficit plan, physical activity prescription per regional guidelines, and behavioral support; visit frequency matched to the ERCG arm.

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) therapy as prescribed during the treatment period. * Known or suspected hypersensitivity to any material/component of the study system. * Pregnant or breastfeeding. * Severe cardiopulmonary disease or other serious systemic/organic disease. * Positive Helicobacter pylori (H. pylori) test. * Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics). * Current systemic corticosteroids, immunosuppressants, or opioid analgesics. * Use of any weight-loss medication within the past 3 months or current use. * Prior use of any intragastric device. * Participation in a weight-affecting clinical trial within the past 6 months. * Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease. * Clinically significant respiratory disease. * Autoimmune connective tissue disease. * Life expectancy \<1 year or severe renal/hepatic/pulmonary or other serious medical illness. * Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight. * Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).

Locations (2)

The fifth Medical Center of Chinese PLA General Hospital, Beijing

Beijing, Beijing Municipality, China