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RECRUITING
NCT07237750
NA

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

Sponsor: Liu Yan

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-03-13

Completion Date

2027-06-30

Last Updated

2026-10-26

Healthy Volunteers

No

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.

PROCEDURE

Sham Endoscopic Procedure

A sham upper gastrointestinal endoscopic procedure performed under the same anesthesia strategy and procedural setting as ERCG. The procedure includes routine examination of the esophagus, stomach, and duodenum and may include non-therapeutic maneuvers such as insufflation, suction, and irrigation. No clips or endoloops are deployed, and no gastric wall traction or gastric volume-reduction procedure is performed. The total procedure-related duration is approximately 25 minutes.

Locations (2)

The fifth Medical Center of Chinese PLA General Hospital, Beijing

Beijing, Beijing Municipality, China

The fifth Medical Center of Chinese PLA General Hospital, Beijing

Beijing, Beijing Municipality, China