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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06934486

Enrollment

250

Registered

2025-04-18

Start date

2026-07-01

Completion date

2028-02-01

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Air Leaks

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.

Interventions

DEVICETissuePatch Sealant Film

Sealant film

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intra-operative air leaks	Prior to the completion of surgery	Air leaks successfully sealed or reduced as assessed by a submersion air leak test

Secondary

Measure	Time frame	Description
Overall device safety	3-months post surgery	Incidence of serious adverse events

Contacts

CONTACTDirector of Clinical Affairs

jaime.ritter@bd.com4043271221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026