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

February 9, 2026 updated by: C. R. Bard

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing lung resection

Description

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 Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with intra-operative air leak detected during lung resection
Device: TissuePatch Sealant Film
Sealant film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prior to the completion of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall device safety
Time Frame: 3-months post surgery
Incidence of serious adverse events
3-months post surgery
Overall device safety
Time Frame: 6-months post-surgery
Adverse events probably or causally related to the study device
6-months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SUR-25TP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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