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

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

Interventions

PROCEDURE

Endoscopic Radial Compression Gastroplasty

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

BEHAVIORAL

Optimized Lifestyle Intervention (OLI)

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

Sponsors & Collaborators

• Wuhan TongJi Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Zhejiang Chinese Medical University

  collaborator OTHER

• Ankang City Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• First Affiliated Hospital of Lanzhou University

  collaborator UNKNOWN

• Liu Yan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2026-12-30

Completion

2027-05-31

Countries

• China

Study Locations