Status:
NOT_YET_RECRUITING
Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
Lead Sponsor:
C. R. Bard
Conditions:
Post-operative Air Leaks
Eligibility:
All Genders
18-80 years
Brief Summary
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
Detailed Description
Post-market study conducted to assess the continuing effectiveness and safety of TissuePatch SF when used as an adjunct to standard suture/staple closure of clinically significant (Macchiarini Grade ≥...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Has or is suspected of having an active infection at or near the planned surgical site
- Has a known allergy or sensitization to TissuePatch SF or its constituent components
- In the investigator's opinion, has a life expectancy of less than 12 months
- 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
- Intra-Operative
Key Trial Info
Start Date :
February 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06934486
Start Date
February 1 2026
End Date
October 1 2027
Last Update
December 3 2025
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