Trials / Not Yet Recruiting
Not Yet RecruitingNCT06934486
Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
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
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TissuePatch Sealant Film | Sealant film |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
- First posted
- 2025-04-18
- Last updated
- 2026-02-10
Source: ClinicalTrials.gov record NCT06934486. Inclusion in this directory is not an endorsement.