[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100333811":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":34,"collaborators":7,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":7,"eligibilityCriteria":41,"healthyVolunteers":38,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":48,"studyType":49,"phases":7,"briefSummary":50,"conditions":51,"keywords":7,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Abigail Lowe","CONTACT","303-724-6070","ABIGAIL.LOWE@UCDENVER.EDU",[15],{"facility":16,"status":17,"city":18,"state":19,"zip":20,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"University of Colorado Hospital","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":24,"coordinates":25},"Point",[26,27],-104.83192,39.72943,{"lat":27,"lon":26},[30,31],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},{"name":32,"role":33,"phone":7,"phoneExt":7,"email":7},"Mihir Wagh, MD","PRINCIPAL_INVESTIGATOR",{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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":46,"type":47},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.",[52,53,54,55,56,57],"Endoscopic Tissue Apposition","Endoscopic Suturing","Endoscopic Clipping","Bariatric Endoscopy","Transoral Outlet Reduction","Endoscopic Sleeve Gastroplasty","2024-05-20",{"date":60,"type":61},"2024-05-21","ACTUAL",{"date":63,"type":61},"2016-12-12",{"date":65,"type":47},"2026-12-16",{"name":5,"class":6},1]