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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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.
* Active infection not successfully eradicated before enrolment.
* 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 it's running

• The fifth Medical Center of Chinese PLA General Hospital, Beijing
  Beijing, Beijing Municipality, China Recruiting
• The fifth Medical Center of Chinese PLA General Hospital, Beijing
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yan Liu, M.D. PH.D.
• Email: 13911798288@163.com
• Phone: +8601066947300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.