Not Yet Recruiting

NCT Number: NCT06934486

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

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

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Key information

Conditions

Post-operative Air Leaks

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Intra-Operative Exclusion Criteria:

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

Treatment and study plan

TissuePatch Sealant Film

Device

Sealant film

Primary outcomes

Intra-operative air leaks

Time frame: Prior to the completion of surgery

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

Secondary outcomes

Overall device safety

Time frame: 3-months post surgery

Incidence of serious adverse events
Overall device safety

Time frame: 6-months post-surgery

Adverse events probably or causally related to the study device

Study contacts

Contact information is provided by the study sponsor or research team.

Director of Clinical Affairs

CONTACT

[email protected]

4043271221

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Apr 18, 2025
Registry last updated: Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.