At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 121 enrolled
Drug / intervention
Standard Tissue Closure Techniques +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Multi-Center Randomized Post Market Study to Evaluate the PleuraSeal Sealant System as Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
In Brief
A Phase 4 clinical trial evaluating Standard Tissue Closure Techniques and PleuraSeal Lung Sealant System for Lung Disease and Pulmonary Lobectomy. Completed, enrolled 121 participants across 9 sites in 6 countries.
Detailed Summary
To further characterize the PleuraSeal Sealant System as compared to standard of care (sutures and staples only) in subjects undergoing an elective pulmonary lobectomy and segmentectomy via open thoractomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Disease, Pulmonary Lobectomy
CountriesAustria, Belgium, Netherlands, Switzerland, United Kingdom, United States
CollaboratorsMedtronic - MITG
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJun 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedJun 24, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.0 years ago
Interventions
Standard Tissue Closure Techniquesprocedure
Standard Tissue Closure Techniques (sutures and staples only)
PleuraSeal Lung Sealant Systemdevice