NCT06934486Not yet recruitingNot Applicable
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
C. R. Bard0 sites250 target enrollmentStarted: July 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- Intra-operative air leaks
Study Overview
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 ≥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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Patients with intra-operative air leak detected during lung resection
Intervention: TissuePatch Sealant Film (Device)
Outcomes
Primary Outcomes
Intra-operative air leaks
Time Frame: Prior to the completion of surgery
Air leaks successfully sealed or reduced as assessed by a submersion air leak test
Secondary Outcomes
- Overall device safety(3-months post surgery)
- Overall device safety(6-months post-surgery)
Investigators
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