[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552557":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Lexington Medical Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL",null,[13],"Device: AEON Endoscopic Powered Stapler Handle and Reload",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","AEON Endoscopic Powered Stapler Handle and Reload","The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload (2.0mm, 2.5mm, 3.25mm, 4.0mm, 5.0mm and 5.5mm).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Antanas Mickevicius","CONTACT","+37069879074","a_mickevicius@yahoo.com",[27],{"facility":28,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Gijos Clinic","RECRUITING","Kaunas","Lithuania","LT",{"type":34,"coordinates":35},"Point",[36,37],23.90909,54.90156,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":11,"phoneExt":11,"email":11},{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100552557","powered-handle-primary-sleeve-gastrectomy-study-100552557",false,"NCT06474637","Powered Handle Primary Sleeve Gastrectomy Study","Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy","Inclusion Criteria:\n\n1. Be within the range of 18-65 years of age\n2. Patients undergoing primary sleeve gastrectomy procedures\n3. Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.\n\nExclusion Criteria:\n\n1. Prior bariatric surgery procedure\n2. Sleeve gastrectomy procedure that is planned to be performed via open approach\n3. Patients receiving anticoagulant medication(s)\n4. Severe heart disease or lung problems\n5. Known sensitivity to implant materials\n6. Evidence of active (systemic or localized) infection at time of surgery\n7. Women who are pregnant or planning to get pregnant in the next 12 months\n8. Recent history of known alcohol and\u002For narcotic abuse\n9. Investigational drug or device use within 30 days\n10. Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study","ALL","18 Years","65 Years",{"count":54,"type":55},100,"ESTIMATED","INTERVENTIONAL",[58],"NA","The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.",[61],"Sleeve Gastrectomy",[63],"LSG (Laparoscopic Sleeve Gastrectomy)","2026-01-13",{"date":66,"type":67},"2026-01-14","ACTUAL",{"date":69,"type":67},"2024-01-30",{"date":71,"type":55},"2028-03",{"name":5,"class":6},1]