Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection
ConditionPost-operative Air Leaks
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorC. R. Bard
About this trial
Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients undergoing lung resection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TissuePatch Sealant Film
DeviceSealant film
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patients with intra-operative air leak detected during lung resection1 intervention
Trial outcomes
Primary outcomes
1
Intra-operative air leaks
Air leaks successfully sealed or reduced as assessed by a submersion air leak test
Time frame
Prior to the completion of surgerySecondary outcomes
1
Overall device safety
Incidence of serious adverse events
Time frame
3-months post surgery2
Overall device safety
Adverse events probably or causally related to the study device
Time frame
6-months post-surgeryLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: