ERCG (clip-and-loop endoscopic gastric reduction) versus optimized lifestyle for weight loss

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

This trial will test whether ERCG, a sutureless endoscopic clip-and-loop procedure that reduces stomach volume, helps Chinese adults with BMI 24.0–37.4 kg/m² lose more weight than an optimized lifestyle program.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing 302 Hospital (Academic / other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07237750 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial will assign eligible Asian adults (BMI 24.0–37.4 kg/m²) 1:1 to either Endoscopic Radial Compression Gastroplasty (ERCG) or an optimized lifestyle intervention. ERCG is a sutureless endoscopic procedure that apposes gastric walls using a clip-and-loop system and is performed under general anesthesia or deep sedation. The primary endpoint is percent total body weight loss (TBWL) at 3 months, with additional safety and metabolic outcomes tracked over follow-up. Early pilot data suggest rapid weight loss after ERCG, but larger randomized data in this population are needed.

Who should consider this trial

Good fit: Asian adults aged 18–65 years with BMI 24.0–37.4 kg/m² who have failed prior conservative weight-loss attempts and can comply with follow-up are ideal candidates.

Not a fit: People with significant upper gastrointestinal disease or prior GI surgery with sequelae, large hiatal hernia or severe refractory GERD, severe coagulopathy, or other listed exclusion conditions are unlikely to benefit from ERCG in this trial.

Why it matters

Potential benefit: If successful, ERCG could offer a less invasive option than surgery that produces rapid, clinically meaningful weight loss in adults with mild-to-moderate obesity.

How similar studies have performed: Early, small studies of ERCG and other endoscopic bariatric therapies have reported rapid weight loss (about 12% TBWL at 3 months) but larger randomized evidence remains limited.

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 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).

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• The fifth Medical Center of Chinese PLA General Hospital, Beijing — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The fifth Medical Center of Chinese PLA General Hospital, Beijing — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yan Liu, M.D. PH.D.

Conditions Overweight and/or Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease; Chinese; Endoscopic gastroplasty; Endoscopic bariatric therapy; Weight loss; Overweight