{ "data": { "asOf": "2026-10-30T22:26:02.113Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07237750", "title": "iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss", "scientificTitle": "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", "status": "recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Overweight and/or Obesity", "Metabolic Syndrome", "Nonalcoholic Fatty Liver Disease" ], "interventions": [ { "name": "Endoscopic Radial Compression Gastroplasty", "type": "PROCEDURE", "description": "Sutureless endoscopic gastric volume reduction using a novel clip-and-endoloop apposition system; performed under general anesthesia or deep sedation; standard perioperative care." }, { "name": "Optimized Lifestyle Intervention (OLI)", "type": "BEHAVIORAL", "description": "Structured nutrition counseling, calorie deficit plan, physical activity prescription per regional guidelines, and behavioral support; visit frequency matched to the ERCG arm." }, { "name": "Sham Endoscopic Procedure", "type": "PROCEDURE", "description": "A sham upper gastrointestinal endoscopic procedure performed under the same anesthesia strategy and procedural setting as ERCG. The procedure includes routine examination of the esophagus, stomach, and duodenum and may include non-therapeutic maneuvers such as insufflation, suction, and irrigation. No clips or endoloops are deployed, and no gastric wall traction or gastric volume-reduction procedure is performed. The total procedure-related duration is approximately 25 minutes." } ], "sponsor": { "name": "Liu Yan", "type": "OTHER" }, "locations": [ { "city": "Beijing", "country": "China", "facility": "The fifth Medical Center of Chinese PLA General Hospital, Beijing" }, { "city": "Beijing", "country": "China", "facility": "The fifth Medical Center of Chinese PLA General Hospital, Beijing" } ], "outcomes": { "other": [], "primary": [ "Percent Total Body Weight Loss (%TBWL)", "Clinical Responder Rate (CRR)" ], "secondary": [ "Body Weight (kg)", "Body Height (m)", "Percent Excess Body Weight Loss (%EBWL)", "Change in BMI (kg/m²)", "Glycated Hemoglobin (HbA1c)", "Adverse Events (AEs/SAEs) Related to Procedure", "GERD-Q Total Score", "Postoperative Pain (VAS/NRS)", "Postoperative Nausea Score", "Total Cholesterol", "Low-Density Lipoprotein Cholesterol (LDL-C)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Asian adults aged 18-65 years.\n* BMI 24.0-27.9 with ≥ 1 obesity-related complication\n* BMI 28.0-37.4kg/m²\n* Failed prior conservative weight loss attempts\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/duodenal ulcer), or neoplastic lesions.\n* Any condition associated with an increased risk of upper gastrointestinal bleeding.\n* Hiatal hernia \\>2 cm or severe/refractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.\n* Esophageal/pharyngeal 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/behavior modification program and/or 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/component of the study system.\n* Pregnant or breastfeeding.\n* Severe cardiopulmonary disease or other serious systemic/organic disease.\n* Active infection not successfully eradicated before enrolment.\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 \\<1 year or severe renal/hepatic/pulmonary 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).", "maximumAge": "65 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 216 }, "startDate": "2026-03-13", "completionDate": "2027-06-30", "lastUpdated": "2026-10-26T00:00:00.000Z", "firstPosted": "2025-11-20T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07237750" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07237750", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07237750", "sourceUrl": "https://clinicaltrials.gov/study/NCT07237750", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:44.629Z", "payloadSha256": "f33031a3a9653c3f275936a570bd71db5ea65dd4e7e29b7b59665325071e3cb6", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07237750", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07237750", "verifyAt": "https://clinicaltrials.gov/study/NCT07237750", "retrievedAt": "2026-10-28T04:32:44.629Z", "payloadSha256": "f33031a3a9653c3f275936a570bd71db5ea65dd4e7e29b7b59665325071e3cb6", "text": "ClinicalTrials.gov, record NCT07237750 (https://clinicaltrials.gov/study/NCT07237750), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; 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