Post-operative Air LeaksNCT06934486
Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
An observational study of Post-operative Air Leaks, run by C. R. Bard.
Trial summary
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-operative Air Leaks
- What is being tested?
- TissuePatch Sealant Film
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lung resection
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
Read the 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
- Being tested
- TissuePatch Sealant Film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissuePatch Sealant FilmDevice
Sealant film
| Study group | Role | What they receive |
|---|---|---|
| Patients with intra-operative air leak detected during lung resection | Not described Receives: Device: TissuePatch Sealant Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative air leaks
Air leaks successfully sealed or reduced as assessed by a submersion air leak test
Measured: Prior to the completion of surgery
Secondary outcomes (2)
Overall device safety
Incidence of serious adverse events
Measured: 3-months post surgery
Overall device safety
Adverse events probably or causally related to the study device
Measured: 6-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Air LeaksStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934486
- Sponsor's protocol ID
- SUR-25TP001
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06934486
- Acronym / sponsor ID
- SUR-25TP001
- Conditions
- Post-operative Air Leaks
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intra-operative air leak detected during lung resection | – | Device: TissuePatch Sealant Film |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lung resection
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TissuePatch Sealant FilmSealant film | Device | Patients with intra-operative air leak detected during lung resection |
Primary outcome
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
2 secondary outcomes
Overall device safety
Time frame: 3-months post surgery
Overall device safety
Time frame: 6-months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Post-operative Air Leaks
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Air Leaks, run by C. R. Bard.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Clinical Affairs (4043271221, jaime.ritter@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative air leaks (time frame: Prior to the completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.