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

Sponsor
Liu Yan
Study ID
NCT07237750
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 20, 2025
Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ERCG + OLI
    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.
  • Active Comparator: OLI
    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.

Primary Outcome Measure

Percent Total Body Weight Loss (%TBWL) [ Time Frame: 1-6 months post-intervention ]

Central Contacts

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