CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 77 enrolled
Drug / intervention
Bio-Seal Track Plug +1 moredevice
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.

Search/NCT00527722
NCT00527722Phase 3Completed
CompareCT.gov

A Prospective Randomized Multi-Centered Study and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures

M.D. Anderson Cancer Center·interventional·Posted Sep 11, 2007·Updated Aug 7, 2012

In Brief

A Phase 3 clinical trial evaluating Bio-Seal Track Plug and No lung plug for Lung Cancer. Completed, enrolled 77 participants across 1 site.

Detailed Summary

The purpose of this study is to demonstrate safety and effectiveness of the Bio-Seal Biopsy Track Plug in a clinical setting for use in lung biopsy procedures to reduce the rate of air leaks, commonly associated with the procedure. The Bio-Seal System is cleared in the U.S. with an indication for use as a lung biopsy site marker.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2007
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.8 years ago

Interventions

Bio-Seal Track Plugdevice

The lung plug will be inserted into the left track when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.

No lung plugother

Standard lung biopsy without placement of the plug.