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

C. R. Bard

Status: Not yet enrolling

Conditions: Post-operative Air Leaks

Treatments: Device: TissuePatch Sealant Film

Study type: Observational

Funder types: Industry

Identifiers

NCT06934486

SUR-25TP001

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 Exclusion Criteria:

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

Trial design

250 participants in 1 patient group

Patients with intra-operative air leak detected during lung resection

Treatment:

Device: TissuePatch Sealant Film