Not Yet RecruitingNot Applicable

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

250 participantsStarted 2026-07-01

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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 air leaks

Timeframe: Prior to the completion of surgery

NCT IDNCT06934486

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-02-01

Director of Clinical Affairs