Actively Recruiting
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
Led by Liu Yan · Updated on 2026-03-13
216
Participants Needed
2
Research Sites
21 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 increasing in Chinese populations, with metabolic risks occurring at lower BMI thresholds than in Western groups. Many people with overweight or mild-to-moderate obesity have not succeeded with conservative weight loss methods and are either ineligible or reluctant to undergo bariatric surgery due to its invasiveness and risks. This trial aims to evaluate a new, less invasive endoscopic procedure called Endoscopic Radial Compression Gastroplasty (ERCG) compared to an optimized lifestyle intervention (OLI) in Chinese adults with a BMI between 24.0 and 37.4 kg/m8 who have not had success with conservative treatments. Participants will be randomly assigned to one of two groups. The ERCG group will undergo a sutureless endoscopic gastric volume reduction using a clip-and-loop system under general anesthesia or deep sedation, followed by a structured lifestyle program including dietary counseling, calorie restriction, physical activity, and behavioral support. The control group will receive the same structured lifestyle program without the ERCG procedure. Follow-up visits will occur at 1, 2, 3, and 6 months after enrollment. During the study, participants will have their weight, BMI, and metabolic parameters such as blood sugar and cholesterol levels measured at various time points. Quality of life will be assessed using validated questionnaires, and any adverse events will be monitored. The main outcome is the percentage of total body weight loss at 3 months. Safety and effectiveness data collected during this trial will help determine if ERCG is a viable option between lifestyle changes and bariatric surgery for overweight and mildly to moderately obese adults.
CONDITIONS
Brief 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 18-65 years
- Body mass index (BMI) between 24.0 and 37.4 kg/m²
- Failed prior conservative weight loss attempts for 2 months or more
- Willing 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, or peptic ulcers
- Conditions that increase risk of upper gastrointestinal bleeding
- Hiatal hernia larger than 2 cm or severe gastroesophageal reflux disease requiring multiple medications
- Structural abnormalities of the esophagus or pharynx that block endoscope passage
- Severe esophageal motility disorders like achalasia
- Severe blood clotting problems
- Insulin-dependent diabetes mellitus
- Chronic abdominal pain or gastrointestinal motility disorders
- Liver impairment or cirrhosis
- Severe or uncontrolled psychiatric illnesses
- Alcohol abuse or substance dependence
- Unwillingness to participate in supervised diet or behavior programs
- Regular use of NSAIDs, anticoagulants, or gastric-irritating medications
- Unable or unwilling to take proton pump inhibitors during treatment
- Known allergy to any component of the study system
- Pregnant or breastfeeding
- Severe heart or lung disease or other serious systemic illnesses
- Positive test for Helicobacter pylori
- Use of medications affected by gastric emptying
- Current use of corticosteroids, immunosuppressants, or opioid analgesics
- Use of weight-loss medications within past 3 months
- Prior use of intragastric devices
- Participation in another weight-affecting clinical trial within 6 months
- Symptomatic heart failure, significant arrhythmia, or unstable coronary artery disease
- Significant respiratory disease
- Autoimmune connective tissue diseases
- Life expectancy less than 1 year or severe kidney, liver, or lung disease
- Known genetic or endocrine causes of obesity
- Eating disorders such as bulimia, binge eating, or compulsive eating disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants in the experimental group undergo the ERCG procedure under general anesthesia or deep sedation, followed by a structured optimized lifestyle intervention (OLI). Participants in the control group receive the structured OLI alone, consisting of individualized nutrition counseling, calorie deficit planning, physical activity prescription, and behavioral support.
Visits at 1 month, 2 months, 3 months, and 6 months after enrollment
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.
Y
Yiyu Qiao, M.D. PH.D.
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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