Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection

Starting soon

Conditions studied: Post-operative Air Leaks

In brief

Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.

Key facts

Study ID

NCT06934486

Run by

C. R. Bard

People needed

250

Starts

2026-07-01

Expected to finish

2028-02-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 Exclusion Criteria:
• >3 identified air leaks
• No air leaks Macchiarini Grade ≥1

Full record on ClinicalTrials.gov

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