Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-04 @ 5:06 AM
Study NCT ID:
NCT07237750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Radial Compression Gastroplasty(ERCG) vs Optimized Lifestyle Intervention for Overweight and Mild-to-Moderate Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Total Body Weight Loss (%TBWL)', 'timeFrame': '3-12 months post-intervention', 'description': '%TBWL = \\[(Baseline weight - Follow-up weight) / Baseline weight\\] × 100. Measured using calibrated scale under standardized conditions.'}, {'measure': 'Percent Excess Body Weight Loss (%EBWL)', 'timeFrame': '3-12 months post-intervention', 'description': '%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 25 kg/m². Weight is measured using a calibrated scale under standardized fasting conditions at each visit.'}], 'secondaryOutcomes': [{'measure': 'Body Weight (kg)', 'timeFrame': 'Baseline, 3 month, 6 months, 12 months', 'description': 'Weight measured on a calibrated scale under standardized conditions (light clothing, no shoes, preferably morning after ≥8h fasting).'}, {'measure': 'Body Height (m)', 'timeFrame': 'Baseline', 'description': 'Standing height measured with a wall-mounted stadiometer, no shoes, heels together, Frankfurt plane horizontal.'}, {'measure': 'Change in BMI (kg/m²)', 'timeFrame': 'Baseling、3、6 and 12 months', 'description': 'BMI will be calculated as weight (kg) divided by height squared (m²).'}, {'measure': 'Glycated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': 'HbA1c will be measured using standard laboratory methods. Values at each visit and changes from baseline will be summarized.'}, {'measure': 'Liver Steatosis Indices', 'timeFrame': 'Baseline,3, 6, 12 months', 'description': 'CAP (dB/m) measured by transient elastography per manufacturer protocol.'}, {'measure': 'Adverse Events (AEs/SAEs) Related to Procedure', 'timeFrame': '3, 6, 12 months', 'description': 'Number and proportion of participants with device-/procedure-related AEs/SAEs, graded by Clavien-Dindo and per FDA/ISO definitions.'}, {'measure': 'GERD-Q Total Score', 'timeFrame': '3, 6, and 12 months', 'description': 'Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score, validated 6-item instrument. Higher scores indicate more severe reflux symptoms.'}, {'measure': 'Postoperative Pain (VAS/NRS)', 'timeFrame': '6 hours, 24 hours, and 7 days', 'description': 'Patient-reported pain intensity using a 0-10 scale (0=no pain, 10=worst imaginable pain). Assessed at rest.'}, {'measure': 'Postoperative Nausea Score', 'timeFrame': '6 hours, 24 hours, and 7 days', 'description': 'Patient-reported nausea severity using a 0-10 numeric rating scale (0=no nausea, 10=worst nausea).'}, {'measure': 'Insulin Resistance Assessed by HOMA-IR', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months', 'description': 'HOMA-IR will be calculated from fasting glucose and insulin concentrations using the standard formula. Higher values indicate greater insulin resistance.'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months', 'description': 'Total cholesterol will be measured after an overnight fast using standard laboratory methods. Values at each visit and changes from baseline will be summarized.'}, {'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months', 'description': 'LDL-C will be measured directly or calculated using standard methods. Values at each visit and changes from baseline will be summarized.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic gastroplasty', 'Endoscopic bariatric therapy', 'Weight loss', 'Overweight', 'Mild obesity', 'Asia', 'Gastric volume reduction'], 'conditions': ['Overweight and/or Obesity', 'Metabolic Syndrome', 'Nonalcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'Obesity and overweight are rising in Asian 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 24.0-34.9 kg/m² who have not succeeded with conservative measures. Preliminary studies suggest ERCG can achieve approximately 15% total body weight loss (TBWL) at 12 months. The primary endpoint is percent TBWL at 12 months; secondary outcomes include changes in BMI, metabolic parameters, liver steatosis/fibrosis indices, 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.', 'detailedDescription': 'The prevalence of obesity and overweight continues to increase worldwide, and Asian populations are particularly vulnerable due to lower thresholds for metabolic risk compared with Western populations. Individuals with overweight or mild-to-moderate obesity (BMI 24.0-34.9 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.\n\nEndoscopic 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 sutureless 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 15% at 12 months, while maintaining a favorable safety profile.\n\nThis randomized controlled trial aims to evaluate the efficacy and safety of ERCG compared with an optimized lifestyle intervention (OLI) in Asian adults with overweight and mild-to-moderate obesity who have failed conservative weight reduction efforts. Eligible participants will be randomized 1:1.5 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 3 months, 6 months, 12 months after enrollment.\n\nThe primary endpoint is percent TBWL at 12 months, assessed using standardized weight measurement protocols. Secondary endpoints include %TBWL at 6 and 12 months, changes in BMI, metabolic parameters (fasting plasma glucose, HbA1c, insulin resistance indices, lipid profile), liver steatosis and fibrosis indices (e.g., controlled attenuation parameter and liver stiffness by transient elastography), quality of life assessed by validated questionnaires (IWQOL-Lite), and the incidence of adverse events classified according to international standards.\n\nRandomization 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.\n\nThe 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 Asian populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asian adults aged 18-70 years.\n* BMI 24.0-34.9 kg/m²(Aisa standard)。\n* Failed prior conservative weight loss attempts ≥3 months。\n* Willingness to comply with follow-up.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Prior bariatric surgery or major upper GI surgery.\n* Significant gastric pathology (e.g., active ulcer, varices, large polyps, malignancy).\n* Severe GERD (LA grade C/D) or hiatal hernia \\>3 cm.\n* Active GI bleeding or coagulopathy not correctable.\n* Serious comorbidities (uncontrolled cardiac, hepatic, renal, or psychiatric disorders).\n* Pregnancy or lactation; planning pregnancy within study period.\n* Use of anti-obesity medications within 3 months.\n* Any condition deemed unsafe by investigators.'}, 'identificationModule': {'nctId': 'NCT07237750', 'acronym': 'ERCG-RCT', 'briefTitle': 'Endoscopic Radial Compression Gastroplasty(ERCG) vs Optimized Lifestyle Intervention for Overweight and Mild-to-Moderate Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'A Prospective, Multicenter, Single-blind, Randomized Controlled Trial Comparing Endoscopic Radial Compression Gastroplasty (ERCG) With Optimized Lifestyle Intervention in Asian Adults With BMI 24.0-34.9 kg/m²', 'orgStudyIdInfo': {'id': '307-2025-ERCG-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERCG + OLI', 'description': '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.', 'interventionNames': ['Procedure: Endoscopic Radial Compression Gastroplasty', 'Behavioral: Optimized Lifestyle Intervention (OLI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OLI', 'description': '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.', 'interventionNames': ['Behavioral: Optimized Lifestyle Intervention (OLI)']}], '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.', 'armGroupLabels': ['ERCG + OLI']}, {'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.', 'armGroupLabels': ['ERCG + OLI', 'OLI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100073', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yan Liu, M.D. PH.D.', 'role': 'CONTACT', 'email': '13911798288@163.com', 'phone': '+8601066947300'}, {'name': 'Yan Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yiyu Qiao', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The fifth Medical Center of Chinese PLA General Hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yan Liu, M.D. PH.D.', 'role': 'CONTACT', 'email': '13911798288@163.com', 'phone': '+8601066947300'}, {'name': 'Yiyu Qiao, M.D. PH.D.', 'role': 'CONTACT', 'email': 'qyy96@126.com', 'phone': '+8601066947300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liu Yan', 'class': 'OTHER'}, 'collaborators': [{'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Soochow University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Gastroenterology, The Fifth Medical Center of PLA General Hospital', 'investigatorFullName': 'Liu Yan', 'investigatorAffiliation': 'Beijing 302 Hospital'}}}}