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

NCT ID: NCT06934486

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-10-01

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.

Conditions

Post-operative Air Leaks

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with intra-operative air leak detected during lung resection

TissuePatch Sealant Film

Intervention Type: DEVICE

Sealant film

Interventions

TissuePatch Sealant Film

Sealant film

Intervention Type: DEVICE

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

1. >3 identified air leaks

2. No air leaks Macchiarini Grade ≥1

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Director of Clinical Affairs

Role: CONTACT

jaime.ritter@bd.com

4043271221

Other Identifiers

SUR-25TP001

Identifier Type: -

Identifier Source: org_study_id