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

NCT06934486 | Not Yet Recruiting

• 1 other identifier: SUR-25TP001
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post-operative Air Leaks

Outcome Measures

Primary Outcomes (1)

• Intra-operative air leaks

  Air leaks successfully sealed or reduced as assessed by a submersion air leak test

  Prior to the completion of surgery

Secondary Outcomes (2)

• Overall device safety

  3-months post surgery

• Overall device safety

  6-months post-surgery

Study Arms (1)

Patients with intra-operative air leak detected during lung resection

Device: TissuePatch Sealant Film

Interventions

TissuePatch Sealant Film DEVICE

Sealant film

Patients with intra-operative air leak detected during lung resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing lung resection

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
• \>3 identified air leaks
• No air leaks Macchiarini Grade ≥1

Sponsors & Collaborators

• C. R. Bard: lead

Central Study Contacts

Director of Clinical Affairs

CONTACT

4043271221; jaime.ritter@bd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share