Recruiting
Not applicable
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
Condition(s) studied
Overweight and/or ObesityMetabolic SyndromeNonalcoholic Fatty Liver DiseaseChinese
Investigational drug(s) / intervention(s)
Endoscopic Radial Compression GastroplastyOptimized Lifestyle Intervention (OLI)
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.
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.
Study 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
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).
Primary outcome measure(s)
- Percent Total Body Weight Loss (%TBWL) — 1-6 months post-intervention
%TBWL = \[(Baseline weight - Follow-up weight) / Baseline weight\] × 100. Measured using calibrated scale under standardized conditions.
- Clinical Responder Rate (CRR) — 3 month, 6 month
Percentage of participants with %TBWL \> 5% at 3/6 months, where %TBWL = \[(baseline weight - month 3/6 weight) / baseline weight\] × 100.
Trial sites (2)
| Facility | City | Region | Status |
|---|
| The fifth Medical Center of Chinese PLA General Hospital, Beijing |
Beijing |
Beijing Municipality |
Not Yet Recruiting |
| The fifth Medical Center of Chinese PLA General Hospital, Beijing |
Beijing |
Beijing Municipality |
Recruiting |
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