iWAIST Trial Comparing Endoscopic Radial Compression Gastroplasty and Optimized Lifestyle Intervention for Weight Loss in Chinese Adults with Overweight or Mild-to-Moderate Obesity

What this Trial Is About

Obesity and overweight are increasing in Chinese populations, with metabolic risks occurring at lower BMI thresholds than in Western groups. Many people with overweight or mild-to-moderate obesity have not succeeded with conservative weight loss methods and are either ineligible or reluctant to undergo bariatric surgery due to its invasiveness and risks. This trial aims to evaluate a new, less invasive endoscopic procedure called Endoscopic Radial Compression Gastroplasty ERCG compared to an optimized lifestyle intervention OLI in Chinese adults with a BMI between 24.0 and 37.4 kgm8 who have not had success with conservative treatments. Participants will be randomly assigned to one of two groups. The ERCG group will undergo a sutureless endoscopic gastric volume reduction using a clip-and-loop system under general anesthesia or deep sedation, followed by a structured lifestyle program including dietary counseling, calorie restriction, physical activity, and behavioral support. The control group will receive the same structured lifestyle program without the ERCG procedure. Follow-up visits will occur at 1, 2, 3, and 6 months after enrollment. During the study, participants will have their weight, BMI, and metabolic parameters such as blood sugar and cholesterol levels measured at various time points. Quality of life will be assessed using validated questionnaires, and any adverse events will be monitored. The main outcome is the percentage of total body weight loss at 3 months. Safety and effectiveness data collected during this trial will help determine if ERCG is a viable option between lifestyle changes and bariatric surgery for overweight and mildly to moderately obese adults.

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