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NCT06934486 | NOT YET RECRUITING | Post-operative Air Leaks

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

C. R. Bard

Brief Summary:

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

Condition or disease

Post-operative Air Leaks

Intervention/treatment

TissuePatch Sealant Film

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 Type : OBSERVATIONAL
Estimated Enrollment : 250 participants
Official Title : 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
Actual Study Start Date : 2025-10-01
Estimated Primary Completion Date : 2027-10-01
Estimated Study Completion Date : 2027-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Is ≥18 and \<80 years of age
  • 2. Undergoing planned (not emergent) video-assisted thoracic surgery pulmonary resection
  • 3. Understands and is willing to comply with all study related procedures
  • 4. Has provided signed informed consent
Exclusion Criteria
  • 1. Women who are pregnant or lactating or, if of childbearing potential, are unwilling to use birth control for 6-months following surgery
  • 2. Has severe congestive heart failure, pulmonary or renal failure, serious haematological disorder or significant liver disease
  • 3. Has previously undergone a pneumonectomy
  • 4. Has a bronchial fistula
  • 5. Has or is suspected of having an active infection at or near the planned surgical site
  • 6. Has a known allergy or sensitization to TissuePatch SF or its constituent components
  • 7. In the investigator's opinion, has a life expectancy of less than 12 months
  • 8. 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
    • 1. \>3 identified air leaks
    • 2. No air leaks Macchiarini Grade ≥1
Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection

Location Details

NCT06934486

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Locations

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