iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLiu Yan
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior gastrointestinal surgery with clinically relevant sequelae.
Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric/duodenal ulcer), or neoplastic lesions.
Any condition associated with an increased risk of upper gastrointestinal bleeding.
Hiatal hernia >2 cm or severe/refractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic Radial Compression Gastroplasty
Procedure/SurgerySutureless 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)
BehavioralStructured nutrition counseling, calorie deficit plan, physical activity prescription per regional guidelines, and behavioral support; visit frequency matched to the ERCG arm.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: ERCG + OLIExperimental treatment 2 interventions
Group B: OLIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Total Body Weight Loss (%TBWL)
%TBWL = \[(Baseline weight - Follow-up weight) / Baseline weight\] × 100. Measured using calibrated scale under standardized conditions.
Time frame
1-6 months post-intervention2
Clinical Responder Rate (CRR)
Percentage of participants with %TBWL \> 5% at 3/6 months, where %TBWL = \[(baseline weight - month 3/6 weight) / baseline weight\] × 100.
Time frame
3 month, 6 monthSecondary outcomes
1
Body Weight (kg)
Weight measured on a calibrated scale under standardized conditions (light clothing, no shoes, preferably morning after ≥8h fasting).
Time frame
Baseline, 1 month, 2 month, 3 month, 6month2
Body Height (m)
Standing height measured with a wall-mounted stadiometer, no shoes, heels together, Frankfurt plane horizontal.
Time frame
Baseline3
Percent Excess Body Weight Loss (%EBWL)
%EBWL is calculated as \[(Baseline weight - Follow-up weight) / (Baseline weight - Ideal weight)\] × 100. Ideal weight is defined as the weight corresponding to a BMI of 23.9 kg/m². Weight is measured using a calibrated scale under standardized fasting conditions at each visit.
Time frame
1-6 months post-intervention4
Change in BMI (kg/m²)
BMI will be calculated as weight (kg) divided by height squared (m²).
Time frame
Baseling, 1 month, 2 months, 3 months and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Liu Yan
Lead sponsor
Beijing 302 Hospital
Sponsor institution
Wuhan TongJi Hospital
Collaborator
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Collaborator
Ankang City Central Hospital
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
LanZhou University
Collaborator
Source ClinicalTrials.gov