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

Launched by C. R. BARD · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a product called TissuePatch SF to see if it can help prevent air leaks that sometimes happen after surgery to remove part of the lung. These air leaks can make recovery more complicated, so the researchers want to find out if using TissuePatch SF can make a difference for patients undergoing this type of surgery.

To be eligible for the study, participants need to be between 18 and 80 years old and have a scheduled surgery for lung resection, which is a planned operation rather than an emergency. They also need to be able to understand the study procedures and agree to follow them. However, certain individuals won’t be able to participate, including those who are pregnant or have serious health issues that could affect the study. If you or a loved one are considering participating, you can expect to receive close monitoring during and after the surgery to evaluate how well TissuePatch SF is working in preventing air leaks. The trial is not yet recruiting, so there will be more information available once it begins.

Gender

ALL

Eligibility 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