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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Percent Total Body Weight Loss (%TBWL)
研究概览
简要总结
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.
详细描述
The prevalence of obesity and overweight continues to increase worldwide, and Chinese populations are particularly vulnerable due to lower thresholds for metabolic risk compared with Western populations. Individuals with overweight or mild-to-moderate obesity (BMI 24.0-37.4 kg/m²) often fail conservative measures but are ineligible or unwilling to undergo bariatric surgery because of its invasiveness, risk, and costs. This creates an unmet need for minimally invasive, effective, and scalable interventions.
Endoscopic bariatric and metabolic therapies (EBMTs) have emerged as alternatives, but many existing procedures involve technically complex endoscopic suturing, high costs, or device-related risks. Investigators developed ERCG, a novel endoscopic procedure that reduces gastric volume by apposing the gastric walls using a newly designed clip-and-loop system. Preliminary studies demonstrated that ERCG can induce rapid weight loss, with mean percent total body weight loss (TBWL) of approximately 12% at 3 months, while maintaining a favorable safety profile.
This randomized controlled trial aims to evaluate the efficacy and safety of ERCG compared with an optimized lifestyle intervention (OLI) in Chinese adults with overweight and mild-to-moderate obesity who have failed conservative weight reduction efforts. Eligible participants will be randomized 1:1 into two groups. The experimental group will undergo ERCG under general anesthesia or deep sedation, following a standardized perioperative protocol, then receive structured OLI. The control group will receive structured OLI consisting of individualized dietary counseling, caloric restriction, exercise prescription, and behavioral support. Follow-up visits are scheduled at 1 month, 2 month, 3 month and 6 month after enrollment.
The primary endpoint is percent TBWL at 3 months, assessed using standardized weight measurement protocols. Secondary endpoints include %EBWL at 3 and 6 months, changes in BMI, metabolic parameters (fasting plasma glucose, HbA1c, insulin resistance indices, lipid profile), quality of life assessed by validated questionnaires (IWQOL-Lite), and the incidence of adverse events classified according to international standards.
Randomization will be computer-generated with concealed allocation, and outcome assessors will be blinded to treatment assignment. Analyses will follow the intention-to-treat principle with appropriate methods for handling missing data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Esophageal/pharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).
- •Achalasia or other severe esophageal motility disorder.
- •Severe coagulopathy.
- •Insulin-dependent diabetes mellitus.
- •Chronic abdominal pain.
- •Gastrointestinal motility disorder (e.g., gastroparesis).
- •Hepatic impairment or cirrhosis.
- •Severe or uncontrolled psychiatric illness.
- •Alcohol abuse or substance dependence.
- •Unwilling to participate in a physician-supervised diet/behavior modification program and/or unwilling to comply with routine follow-up.
- •Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.
- •Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during the treatment period.
- •Known or suspected hypersensitivity to any material/component of the study system.
- •Pregnant or breastfeeding.
- •Severe cardiopulmonary disease or other serious systemic/organic disease.
- •Positive Helicobacter pylori (H. pylori) test.
- •Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics).
- •Current systemic corticosteroids, immunosuppressants, or opioid analgesics.
- •Use of any weight-loss medication within the past 3 months or current use.
- •Prior use of any intragastric device.
- •Participation in a weight-affecting clinical trial within the past 6 months.
- •Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease.
- •Clinically significant respiratory disease.
- •Autoimmune connective tissue disease.
- •Life expectancy <1 year or severe renal/hepatic/pulmonary or other serious medical illness.
- •Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight.
- •Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).
研究组 & 干预措施
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.
干预措施: Endoscopic Radial Compression Gastroplasty (Procedure)
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.
干预措施: Optimized Lifestyle Intervention (OLI) (Behavioral)
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.
干预措施: Optimized Lifestyle Intervention (OLI) (Behavioral)
结局指标
主要结局
Percent Total Body Weight Loss (%TBWL)
时间窗: 1-6 months post-intervention
%TBWL = \[(Baseline weight - Follow-up weight) / Baseline weight\] × 100. Measured using calibrated scale under standardized conditions.
Clinical Responder Rate (CRR)
时间窗: 3 month, 6 month
Percentage of participants with %TBWL \> 5% at 3/6 months, where %TBWL = \[(baseline weight - month 3/6 weight) / baseline weight\] × 100.
次要结局
- Body Weight (kg)(Baseline, 1 month, 2 month, 3 month, 6month)
- Body Height (m)(Baseline)
- Percent Excess Body Weight Loss (%EBWL)(1-6 months post-intervention)
- Change in BMI (kg/m²)(Baseling, 1 month, 2 months, 3 months and 6 months)
- Glycated Hemoglobin (HbA1c)(Baseline, 3 months)
- Adverse Events (AEs/SAEs) Related to Procedure(3, 6, 12 months)
- GERD-Q Total Score(Baseline, 3, and 6 months)
- Postoperative Pain (VAS/NRS)(6 hours, 24 hours, and 7 days)
- Postoperative Nausea Score(6 hours, 24 hours, and 7 days)
- Total Cholesterol(Baseline, 3 months)
- Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, 3 months)
研究者
Liu Yan
Principal Investigator, Department of Gastroenterology, Chinese PLA General Hospital
Beijing 302 Hospital