[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587907":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":32,"overallOfficials":21,"centralContacts":38,"locations":21,"responsibleParty":44,"collaborators":21,"id":46,"slug":21,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":21,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":21,"studyType":58,"phases":21,"briefSummary":59,"conditions":60,"keywords":21,"overallStatus":62,"whyStopped":21,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":21},{"fullName":5,"class":6},"C. R. Bard","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Intra-operative air leaks","Air leaks successfully sealed or reduced as assessed by a submersion air leak test","Prior to the completion of surgery",[14,18],{"measure":15,"description":16,"timeFrame":17},"Overall device safety","Incidence of serious adverse events","3-months post surgery",{"measure":15,"description":19,"timeFrame":20},"Adverse events probably or causally related to the study device","6-months post-surgery",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","Post-market study conducted to assess the continuing effectiveness and safety of TissuePatch SF when used as an adjunct to standard suture\u002Fstaple closure of clinically significant (Macchiarini Grade ≥1) intra-operative visceral pleural air leaks incurred during lobectomy and segmentectomy (open or minimally invasive), including those performed as video-assisted thoracic surgery (VATS), in adults.","Patients undergoing lung resection",[28],{"label":29,"type":21,"description":21,"interventionNames":30},"Patients with intra-operative air leak detected during lung resection",[31],"Device: TissuePatch Sealant Film",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":21},"DEVICE","TissuePatch Sealant Film","Sealant film",[29],[39],{"name":40,"role":41,"phone":42,"phoneExt":21,"email":43},"Director of Clinical Affairs","CONTACT","4043271221","jaime.ritter@bd.com",{"type":45,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","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":56,"type":57},250,"ESTIMATED","OBSERVATIONAL","Post-market, observational study to assess effectiveness of TissuePatch SF in managing\u002Fpreventing air leaks after lung resection.",[61],"Post-operative Air Leaks","NOT_YET_RECRUITING","2026-02-09",{"date":65,"type":66},"2026-02-10","ACTUAL",{"date":68,"type":57},"2026-07-01",{"date":70,"type":57},"2028-02-01",{"name":5,"class":6}]