Endoscopic stomach procedure plus lifestyle support for weight loss in overweight or obese adults
Tests a stomach-shrinking endoscopic procedure against a sham procedure in adults with overweight or obesity.
Plain-language title generated from the registry record
Registry title: iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07237750, who can take part
Where in China
- The fifth Medical Center of Chinese PLA General Hospital, BeijingBeijing, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Liu Yan
- Trial code
- NCT07237750
- Record updated
- 26 October 2026
- Original description
This randomized, sham-controlled trial evaluates the efficacy and safety of ERCG plus optimized lifestyle intervention compared with sham procedure plus optimized lifestyle intervention in Chinese adults with overweight accompanied by at least one metabolic comorbidity or with mild-to-moderate obesity. The co-primary outcomes are percentage total weight loss (%TWL) at 12 weeks and the clinical response rate at 12 weeks, defined as the proportion of participants achieving %TWL ≥5%. Secondary outcomes include weight-related, metabolic, hepatic steatosis-related, imaging, symptom, quality-of-life, and safety outcomes.Read full original descriptionShow less
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 randomized, sham-controlled trial evaluates the efficacy and safety of ERCG plus optimized lifestyle intervention compared with sham procedure plus optimized lifestyle intervention in Chinese adults with overweight accompanied by at least one metabolic comorbidity or with mild-to-moderate obesity. The co-primary outcomes are percentage total weight loss (%TWL) at 12 weeks and the clinical response rate at 12 weeks, defined as the proportion of participants achieving %TWL ≥5%. Secondary outcomes include weight-related, metabolic, hepatic steatosis-related, imaging, symptom, quality-of-life, and safety outcomes.
Inclusion: Asian adults aged 18-65 years; BMI 24.0-27.9 with ≥ 1 obesity-related complication; BMI 28.0-37.4kg/m²; Failed prior conservative weight loss attempts; Willingness to comply with follow-up; Provided written informed consent.
Exclusion: Prior gastrointestinal surgery with clinically relevant sequelae; 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; 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; 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; Achalasia or other severe esophageal motility disorder; Insulin-dependent diabetes mellitus; Gastrointestinal motility disorder (e.g., gastroparesis); Hepatic impairment or cirrhosis; Severe or uncontrolled psychiatric illness; Known or suspected hypersensitivity to any material/component of the study system; Severe cardiopulmonary disease or other serious systemic/organic disease; Active infection not successfully eradicated before enrolment; 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); Esophageal/pharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum); Severe coagulopathy; Chronic abdominal pain; 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; Pregnant or breastfeeding; Participation in a weight-affecting clinical trial within the past 6 months.