Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
ConditionPost-operative Air Leaks
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorC. R. Bard
About this trial
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
Eligibility criteria
Qualifiers
Is ≥18 and <80 years of age
Undergoing planned (not emergent) video-assisted thoracic surgery pulmonary resection
Understands and is willing to comply with all study related procedures
Has provided signed informed consent
Disqualifiers
Women who are pregnant or lactating or, if of childbearing potential, are unwilling to use birth control for 6-months following surgery
Has severe congestive heart failure, pulmonary or renal failure, serious haematological disorder or significant liver disease
Has previously undergone a pneumonectomy
Has a bronchial fistula
Trial design
Treatments tested in this trial
- TissuePatch Sealant Film
Treatment groups
250 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov