At a glance
ClinicalIndex Comparison RecordN/ACompleted· 207 enrolled
Drug / intervention
Progel® Pleural Air Leak Sealantdevice
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.
A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
In Brief
A clinical study evaluating Progel® Pleural Air Leak Sealant for Pulmonary Disease. Completed, enrolled 207 participants across 15 sites.
Detailed Summary
The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries. The data collected in this clinical study will supplement the Approved PMA P010047 Progel® PALS product.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionApr 2014
TodayJul 2026
First PostedJun 4, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.1 years ago
Interventions
Progel® Pleural Air Leak Sealantdevice
Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant