[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428075":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":42,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":42,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":42,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":42,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Mater Olbia Hospital","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing Endoscopic Sleeve Gastroplasty","ACTIVE_COMPARATOR","Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg\u002Fm2) and previous failed attempts of diet.",[13],"Procedure: Endoscopic gastroplasty",{"label":15,"type":10,"description":11,"interventionNames":16},"Patients undergoing Endoluminal Vertical Gastroplasty",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Patients undergoing Primary Obesity Surgical Endolumenal 2",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Endoscopic gastroplasty","Endoscopic Gastroplasty",[15,9,18],[27,28,29],"Apollo Overstitch Sx","Endomina","POSE2",[31,35],{"name":32,"affiliation":33,"role":34},"Salvatore F. Vadalà di Prampero, MD, PhD","Gastroenterology and GI Endoscopy","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":33,"role":37},"Milutin Bulajic, MD, PhD","STUDY_CHAIR",[39],{"name":32,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","00393492666795",null,"vadaladiprampero@gmail.com",[45],{"facility":5,"status":46,"city":47,"state":42,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Olbia","07026","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],9.49802,40.92337,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":41,"phoneExt":42,"email":43},"Salvatore F. Vadalà di Prampero, MD, Phd",{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Salvatore F. Vadalà di Prampero","Principal Investigator","100428075","bariatric-endoscopy-for-treatment-of-obesity-100428075",false,"NCT04854317","Bariatric Endoscopy for Treatment of Obesity","Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial","Inclusion Criteria:\n\n* age \\> 18 years old;\n* acceptance of written informed consent to undergo an EG;\n* capability to understand and comply with the study protocol;\n* obesity: a BMI of 30-34.99 kg\u002Fm2 with previous failed attempts at diet and with obesity-related diseases, a BMI of 35-39.99 kg\u002Fm2 with previous failed attempts at diet and with or without obesity-related diseases, a BMI of 40-44.99 kg\u002Fm2 with previous failed attempts at diet and with or without obesity-related diseases not fit for surgery.\n\nExclusion Criteria:\n\n* patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason;\n* patients suffering from any condition which precludes compliance with study instructions;\n* patients who underwent previous attempts at surgical or endoscopic bariatric therapy;\n* patient has any allergy or other known contraindication or intolerance to the medications used in the study;\n* women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice methods of contraception;\n* patient suffers from a life threatening condition.","ALL","18 Years","70 Years",{"count":74,"type":75},189,"ESTIMATED","INTERVENTIONAL",[78],"NA","A single-center, randomized trial will be conducted in order to compare three Endoscopic Gastroplasty (EG) techniques in obese patients (BMI 30-44.99 kg\u002Fm2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment \\& Gemelli Foundation, Italy in period June 2020 - August 2024, with the aim to compare the efficacy and safety of these procedures.",[81],"Obesity",[83,84,85,86,87],"Weight","Obese","Endoscopic Sleeve Gastroplasty","Endoluminal Vertical Gastroplasty","Primary Obesity Surgical Endolumenal 2","2025-01-30",{"date":90,"type":91},"2025-02-03","ACTUAL",{"date":93,"type":91},"2020-06-19",{"date":95,"type":75},"2025-02",{"name":5,"class":6},1]