Actively Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
Led by Liu Yan · Updated on 2026-03-13
216
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
L
Liu Yan
Lead Sponsor
W
Wuhan TongJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Asian adults aged 18 to 65 years
- BMI between 24.0 and 37.4 kg/m² according to Chinese standards
- Failed prior conservative weight loss attempts lasting 2 months or more
- Willingness to comply with follow-up visits
- Provided written informed consent
You will not qualify if you...
- Prior gastrointestinal surgery with significant complications
- Active or significant gastrointestinal diseases such as esophagitis, Barrett's esophagus, Crohn's disease, peptic ulcers, or tumors
- Conditions increasing risk of upper gastrointestinal bleeding
- Hiatal hernia larger than 2 cm or severe gastroesophageal reflux disease requiring 2 or more medications
- Structural abnormalities of esophagus or pharynx that block endoscope passage
- Achalasia or severe esophageal motility disorders
- Severe bleeding disorders
- Insulin-dependent diabetes mellitus
- Chronic abdominal pain or gastrointestinal motility disorders like gastroparesis
- Liver impairment or cirrhosis
- Severe or uncontrolled psychiatric illness
- Alcohol abuse or substance dependence
- Unwillingness to follow physician-supervised diet or behavioral programs or routine follow-up
- Regular daily use of NSAIDs, anticoagulants, or other stomach-irritating medications
- Inability or unwillingness to take proton pump inhibitors during treatment
- Known or suspected allergy to any study system materials
- Pregnancy or breastfeeding
- Severe cardiopulmonary or other serious systemic diseases
- Positive Helicobacter pylori test
- Use of medications affected by gastric emptying such as antiepileptics or antiarrhythmics
- Current use of systemic corticosteroids, immunosuppressants, or opioid analgesics
- Use of any weight-loss medication within the past 3 months or current use
- Prior use of intragastric devices
- Participation in other weight-affecting clinical trials within the past 6 months
- Symptomatic congestive heart failure, significant arrhythmias, or unstable coronary artery disease
- Significant respiratory disease
- Autoimmune connective tissue disease
- Life expectancy less than 1 year or severe renal, hepatic, pulmonary, or other serious illness
- Known genetic or endocrine causes of obesity such as hypothyroidism or Prader-Willi syndrome
- Eating disorders including night eating syndrome, bulimia, binge eating, or compulsive eating disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The fifth Medical Center of Chinese PLA General Hospital, Beijing
Beijing, Beijing Municipality, China, 100073
Not Yet Recruiting
2
The fifth Medical Center of Chinese PLA General Hospital, Beijing
Beijing, Beijing Municipality, China, 100073
Actively Recruiting
Research Team
Y
Yan Liu, M.D. PH.D.
CONTACT
Y
Yiyu Qiao, M.D. PH.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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