[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endoscopic-sleeve-gastroplasty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endoscopic-sleeve-gastroplasty":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100333811","prospective-evaluation-of-the-efficacy-and-safety-of-endoscopic-tissue-apposition-100333811",false,"NCT03626194","Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition","Inclusion Criteria:\n\n* Patients\\>18 years of age undergoing endoscopy for any of the following indications:\n\nIndications for Tissue Apposition:\n\n* Closure of perforations\n* Closure of full thickness defects created during endoscopic full thickness resection\n* Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection\n* Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)\n* Stent fixation\n* Closure of fistulas\n* Natural Orifice Transluminal Endoscopic Surgery defect closures\n* Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)\n* Primary endoscopic sleeve gastroplasty\n\nExclusion Criteria:\n\n* Patients unable or unwilling to provide consent\n* Pregnant patients\n* Coagulation disorders (INR \\>1.8, platelet \\\u003C50,000)\n* GI Bleeding\n* Hemodynamic instability\n* Enrollment in another device or drug study that may confound the results","ALL","18 Years","89 Years",{"count":19,"type":20},500,"ESTIMATED","2 Years","OBSERVATIONAL","This study is a prospective registry of patients undergoing endoscopic suturing and\u002For clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.\n\n1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.\n\n1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.",[25,26,27,28,29,30],"Endoscopic Tissue Apposition","Endoscopic Suturing","Endoscopic Clipping","Bariatric Endoscopy","Transoral Outlet Reduction","Endoscopic Sleeve Gastroplasty","RECRUITING","2024-05-20",{"date":34,"type":35},"2024-05-21","ACTUAL",{"date":37,"type":35},"2016-12-12",{"date":39,"type":20},"2026-12-16",{"name":41,"class":42},"University of Colorado, Denver","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100542165","endoscopic-sleeve-gastroplasty-esg-for-the-treatment-of-obesity-100542165","NCT06339320","Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity","Inclusion Criteria:\n\n* Patients with BMI 30 to 50 kg\u002Fm2\n* Patients that have been unable able to lose weight, or maintain weight loss, through more conservative measures (i.e., lifestyle interventions including diet and exercise) per the FDA approval for the Apollo ESG device. Lifestyle interventions may include traditional diet and anaerobic or aerobic exercise, including resistance training.\n\nExclusion Criteria:\n\n* Patients who are actively pregnant\n* Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)\n* Active gastric mucosal lesions\n* Active bleeding or potential bleeding gastric lesions (i.e., ulcers, erosive gastritis, varices, or vascular malformations)\n* Neoplastic lesions (i.e., esophageal, gastric, or small bowel cancer)\n* Hiatal hernia \\>5 cm\n* Severe coagulopathy and antiplatelet\u002Fanticoagulant therapy that cannot be corrected\n* Psychiatric disorders not assessed or cleared by a psychologist or psychiatrist actively participating in that patient's care (i.e., affective disorders not under medical supervision or refractory to medical therapy and all eating disorders such as anorexia nervosa, binge eating disorder, specified feeding and eating disorders, avoidant restrictive food intake, and rumination)\n* Patients with endoscopic interventions that are contraindicated",{"count":51,"type":20},150,"INTERVENTIONAL",[54],"NA","The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg\u002Fm2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).",[30,57],"Obesity",[57,59,60],"Weight loss","Endoscopic Sleeve Gastroplasty (ESG)","2024-03-24",{"date":63,"type":35},"2024-04-01",{"date":65,"type":35},"2024-02-28",{"date":67,"type":20},"2033-10",{"name":69,"class":42},"The Methodist Hospital Research Institute",2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":52,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":43},"100509773","endoscopic-sleeve-gastroplasty-with-endomina-for-the-treatment-of-obesity-in-kidney-transplant-candidates-100509773","NCT05917795","Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates","Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates","ESGiTXKidney","Inclusion Criteria:\n\n* Adult patients (i.e., age between 18 and 70 years).\n* BMI ≥ 35 kg\u002Fm²;\n* Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate \\[GFR\\] \\\u003C30ml\u002Fmin\u002F1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible;\n* Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg\u002Fm2);\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients on peritoneal dialysis\n* Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months;\n* Ongoing or active malignancy during the last 5 years\n* Myocardial infarction during the past 6 months or\u002Fand heart failure class III or IV according to the New York Heart association's classification;\n* Previous stomach, oesophagus or duodenum surgery;\n* Technical non-feasibility in the opinion of the endoscopist;\n* Clinical signs of active infection;\n* Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);\n* Active drugs or alcohol abuse;\n* Pregnancy, lactation (desire to become pregnant during study duration);\n* Enrolment in other clinical studies;\n* Contraindication to general anaesthesia;\n* Other conditions to exclude the subject in investigators opinion;\n* Refusal to sign informed consent. -","70 Years",{"count":81,"type":20},24,[54],"The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg\u002Fm2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. The main question\\[s\\] it aims to answer are:\n\nIs the procedure effective in reducing BMI to the target level in 12 months? Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.",[85,86,87,30],"Obesity, Morbid","End Stage Renal Disease","Kidney Transplantation","2024-02-26",{"date":65,"type":35},{"date":91,"type":35},"2023-09-24",{"date":93,"type":20},"2027-07-01",{"name":95,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]