Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TissuePatch Sealant Film.
- Who it may be relevant to
- Registry conditions: Post-operative Air Leaks. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Device TissuePatch Sealant Film
Sealant film
Primary outcome measures
- Intra-operative air leaks [Time frame: Prior to the completion of surgery]
Secondary outcome measures (2)
- Overall device safety [Time frame: 3-months post surgery]
- Overall device safety [Time frame: 6-months post-surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06934486 · SUR-25TP001