At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 339 enrolled
Drug / intervention
Bio-Seal Plugdevice
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, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy
In Brief
A Phase 3 clinical trial evaluating Bio-Seal Plug for Pneumothorax. Completed, enrolled 339 participants across 18 sites.
Detailed Summary
BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumothorax
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
First PostedNov 2007
Primary CompletionJun 2008
Study CompletionAug 2008
TodayJul 2026
First PostedNov 22, 2007
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.6 years ago
Interventions
Bio-Seal Plugdevice
Deployment of the Bio-Seal plug in needle track