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