iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss
NCT ID: NCT07237750
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2026-01-01
2027-05-31
Brief Summary
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Detailed Description
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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.
The study is expected to generate high-quality evidence regarding the short-term and medium-term efficacy of ERCG, to clarify its safety profile, and to determine whether ERCG can serve as a safe and scalable option bridging the therapeutic gap between conservative lifestyle approaches and bariatric surgery for overweight and mildly to moderately obese Chinese populations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
65 Years
ALL
No
Sponsors
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Wuhan TongJi Hospital
OTHER
The Second Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
Ankang City Central Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
First Affiliated Hospital of Lanzhou University
UNKNOWN
Liu Yan
OTHER
Responsible Party
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Liu Yan
Principal Investigator, Department of Gastroenterology, Chinese PLA General Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yan Liu, M.D. PH.D.
Role: primary
Other Identifiers
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307-2026-iWAIST-RCT
Identifier Type: -
Identifier Source: org_study_id