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iWAIST Trial: A Multicenter, Open Label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Endoscopic Radial Compression Gastroplasty (ERCG) Versus Optimized Lifestyle Intervention for Weight Loss in Chinese Adults With Overweight or Obesity

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Asian adults aged 18-65 years.

• BMI 24.0-37.4kg/m²(Chinese standard)。

• Failed prior conservative weight loss attempts ≥2 months。

• Willingness to comply with follow-up.

• Provided written informed consent.

Locations
Other Locations
China
The fifth Medical Center of Chinese PLA General Hospital, Beijing
NOT_YET_RECRUITING
Beijing
The fifth Medical Center of Chinese PLA General Hospital, Beijing
RECRUITING
Beijing
Contact Information
Primary
Yan Liu, M.D. PH.D.
13911798288@163.com
+8601066947300
Backup
Yiyu Qiao, M.D. PH.D.
qyy96@126.com
+8601066947300
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 216
Treatments
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.
Sponsors
Collaborators: First Affiliated Hospital of Lanzhou University, The First Affiliated Hospital of Soochow University, Wuhan TongJi Hospital, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Ankang City Central Hospital
Leads: Liu Yan

This content was sourced from clinicaltrials.gov