iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

NCT07237750 | Recruiting

• 1 other identifier: 307-2026-iWAIST-RCT
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

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

Overweight and/or Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease; Chinese

Keywords

Endoscopic gastroplasty; Endoscopic bariatric therapy; Weight loss; Overweight; Gastric volume reduction; Chinese; Obesity

Outcome Measures

Primary Outcomes (2)

• Percent Total Body Weight Loss (%TBWL)

  %TBWL = \[(Baseline weight - Follow-up weight) / Baseline weight\] × 100. Measured using calibrated scale under standardized conditions.

  1-6 months post-intervention

• Clinical Responder Rate (CRR)

  Percentage of participants with %TBWL \> 5% at 3/6 months, where %TBWL = \[(baseline weight - month 3/6 weight) / baseline weight\] × 100.

  3 month, 6 month

Secondary Outcomes (11)

• Body Weight (kg)

  Baseline, 1 month, 2 month, 3 month, 6month

• Body Height (m)

  Baseline

• Percent Excess Body Weight Loss (%EBWL)

  1-6 months post-intervention

• Change in BMI (kg/m²)

  Baseling, 1 month, 2 months, 3 months and 6 months

• Glycated Hemoglobin (HbA1c)

  Baseline, 3 months

Study Arms (2)

ERCG + OLI

EXPERIMENTAL

Sutureless endoscopic gastric volume reduction using a clip-and-loop apposition system under general anesthesia or deep sedation, plus standardized OLI (dietary counseling, calorie deficit, physical activity prescription, and behavioral support) with visit frequency matched to the comparator.

Procedure: Endoscopic Radial Compression Gastroplasty; Behavioral: Optimized Lifestyle Intervention (OLI)

OLI

ACTIVE COMPARATOR

Structured lifestyle program including individualized nutrition counseling targeting a 【\~500-750 kcal/day】 deficit, physical activity prescription (≥150 min/week moderate-intensity plus resistance training twice weekly), and behavioral support delivered at the same schedule as the experimental arm.

Behavioral: Optimized Lifestyle Intervention (OLI)

Interventions

Endoscopic Radial Compression Gastroplasty PROCEDURE

Sutureless endoscopic gastric volume reduction using a novel clip-and-endoloop apposition system; performed under general anesthesia or deep sedation; standard perioperative care.

ERCG + OLI

Optimized Lifestyle Intervention (OLI) BEHAVIORAL

Structured nutrition counseling, calorie deficit plan, physical activity prescription per regional guidelines, and behavioral support; visit frequency matched to the ERCG arm.

ERCG + OLI; OLI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liu Yan: lead
• Wuhan TongJi Hospital: collaborator
• The Second Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Ankang City Central Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• First Affiliated Hospital of Lanzhou University: collaborator

Study Sites (2)

The fifth Medical Center of Chinese PLA General Hospital, Beijing

Beijing, Beijing Municipality, 100073, China

NOT YET RECRUITING

The fifth Medical Center of Chinese PLA General Hospital, Beijing

Beijing, Beijing Municipality, 100073, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Weight Loss; Overweight; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders

Central Study Contacts

Yan Liu, M.D. PH.D.

CONTACT

+8601066947300; 13911798288@163.com

Yiyu Qiao, M.D. PH.D.

CONTACT

+8601066947300; qyy96@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Gastroenterology, Chinese PLA General Hospital

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 20, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (2)