[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587907":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":10,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":10,"studyType":40,"phases":10,"briefSummary":41,"conditions":42,"keywords":10,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":10},{"fullName":5,"class":6},"C. R. Bard","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Patients with intra-operative air leak detected during lung resection",null,[12],"Device: TissuePatch Sealant Film",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","TissuePatch Sealant Film","Sealant film",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Director of Clinical Affairs","CONTACT","4043271221","jaime.ritter@bd.com",{"type":26,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100587907","observational-study-of-tissuepatch-sf-in-prevention-of-air-leaks-following-lung-resection-100587907",false,"NCT06934486","Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection","A Multi-Centre Prospective, Non-Comparative, Open, Post-Marketing Surveillance Study to Obtain Clinical Outcome Data on the Use of Tissue Patch in the Prevention of Air Leaks Following Lung Resection","Inclusion Criteria:\n\n1. Is ≥18 and \\\u003C80 years of age\n2. Undergoing planned (not emergent) video-assisted thoracic surgery pulmonary resection\n3. Understands and is willing to comply with all study related procedures\n4. Has provided signed informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating or, if of childbearing potential, are unwilling to use birth control for 6-months following surgery\n2. Has severe congestive heart failure, pulmonary or renal failure, serious haematological disorder or significant liver disease\n3. Has previously undergone a pneumonectomy\n4. Has a bronchial fistula\n5. Has or is suspected of having an active infection at or near the planned surgical site\n6. Has a known allergy or sensitization to TissuePatch SF or its constituent components\n7. In the investigator's opinion, has a life expectancy of less than 12 months\n8. Has, in the investigator's opinion, any disease or condition, physical or psychological, that could interfere with the evaluation of TissuePatch SF or compliance with study procedures\n\nIntra-Operative Exclusion Criteria:\n\n1. \\>3 identified air leaks\n2. No air leaks Macchiarini Grade ≥1","ALL","18 Years","80 Years",{"count":38,"type":39},250,"ESTIMATED","OBSERVATIONAL","Post-market, observational study to assess effectiveness of TissuePatch SF in managing\u002Fpreventing air leaks after lung resection.",[43],"Post-operative Air Leaks","NOT_YET_RECRUITING","2026-02-09",{"date":47,"type":48},"2026-02-10","ACTUAL",{"date":50,"type":39},"2026-07-01",{"date":52,"type":39},"2028-02-01",{"name":5,"class":6}]