[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611220":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":69,"collaborators":73,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ERCG + OLI","EXPERIMENTAL","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.",[13,14],"Procedure: Endoscopic Radial Compression Gastroplasty","Behavioral: Optimized Lifestyle Intervention (OLI)",{"label":16,"type":17,"description":18,"interventionNames":19},"OLI","ACTIVE_COMPARATOR","Structured lifestyle program including individualized nutrition counseling targeting a 【\\~500-750 kcal\u002Fday】 deficit, physical activity prescription (≥150 min\u002Fweek moderate-intensity plus resistance training twice weekly), and behavioral support delivered at the same schedule as the experimental arm.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","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.",[9,16],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Yan Liu, M.D. PH.D.","CONTACT","+8601066947300","13911798288@163.com",{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},"Yiyu Qiao, M.D. PH.D.","qyy96@126.com",[42,64],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The fifth Medical Center of Chinese PLA General Hospital, Beijing","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100073","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57,58,61],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Yan Liu","PRINCIPAL_INVESTIGATOR",{"name":62,"role":63,"phone":26,"phoneExt":26,"email":26},"Yiyu Qiao","SUB_INVESTIGATOR",{"facility":43,"status":65,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":68,"contacts":26},"RECRUITING",{"type":51,"coordinates":67},[53,54],{"lat":54,"lon":53},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Liu Yan","Principal Investigator, Department of Gastroenterology, Chinese PLA General Hospital",[74,76,78,80,82],{"name":75,"class":6},"Wuhan TongJi Hospital",{"name":77,"class":6},"The Second Affiliated Hospital of Zhejiang Chinese Medical University",{"name":79,"class":6},"Ankang City Central Hospital",{"name":81,"class":6},"The First Affiliated Hospital of Soochow University",{"name":83,"class":6},"LanZhou University","100611220","iwaist-trial-ercg-endoscopic-radial-compression-gastroplasty-vs-optimized-lifestyle-intervention-for-weight-loss-100611220",false,"NCT07237750","iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss","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","iWAIST-RCT","Inclusion Criteria:\n\n* Asian adults aged 18-65 years.\n* BMI 24.0-37.4kg\u002Fm²(Chinese standard)。\n* Failed prior conservative weight loss attempts ≥2 months。\n* Willingness to comply with follow-up.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Prior gastrointestinal surgery with clinically relevant sequelae.\n* Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric\u002Fduodenal ulcer), or neoplastic lesions.\n* Any condition associated with an increased risk of upper gastrointestinal bleeding.\n* Hiatal hernia \\>2 cm or severe\u002Frefractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.\n* Esophageal\u002Fpharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).\n* Achalasia or other severe esophageal motility disorder.\n* Severe coagulopathy.\n* Insulin-dependent diabetes mellitus.\n* Chronic abdominal pain.\n* Gastrointestinal motility disorder (e.g., gastroparesis).\n* Hepatic impairment or cirrhosis.\n* Severe or uncontrolled psychiatric illness.\n* Alcohol abuse or substance dependence.\n* Unwilling to participate in a physician-supervised diet\u002Fbehavior modification program and\u002For unwilling to comply with routine follow-up.\n* Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.\n* Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during the treatment period.\n* Known or suspected hypersensitivity to any material\u002Fcomponent of the study system.\n* Pregnant or breastfeeding.\n* Severe cardiopulmonary disease or other serious systemic\u002Forganic disease.\n* Positive Helicobacter pylori (H. pylori) test.\n* Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics).\n* Current systemic corticosteroids, immunosuppressants, or opioid analgesics.\n* Use of any weight-loss medication within the past 3 months or current use.\n* Prior use of any intragastric device.\n* Participation in a weight-affecting clinical trial within the past 6 months.\n* Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease.\n* Clinically significant respiratory disease.\n* Autoimmune connective tissue disease.\n* Life expectancy \\\u003C1 year or severe renal\u002Fhepatic\u002Fpulmonary or other serious medical illness.\n* Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight.\n* Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).","ALL","18 Years","65 Years",{"count":96,"type":97},216,"ESTIMATED","INTERVENTIONAL",[100],"NA","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\u002Fm² 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.",[103,104,105,106],"Overweight and\u002For Obesity","Metabolic Syndrome","Nonalcoholic Fatty Liver Disease","Chinese",[108,109,110,111,112,106,113],"Endoscopic gastroplasty","Endoscopic bariatric therapy","Weight loss","Overweight","Gastric volume reduction","Obesity","2026-03-11",{"date":116,"type":117},"2026-03-13","ACTUAL",{"date":119,"type":117},"2026-03-01",{"date":121,"type":97},"2027-05-31",{"name":71,"class":6},2]