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Evaluation of the Bio-Seal Biopsy Track Plug

NCT00527722 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2012-08-07

Study results available
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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.

Conditions

Interventions

DEVICE

Bio-Seal Track Plug

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.

OTHER

No lung plug

Standard lung biopsy without placement of the plug.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sanjay Gupta, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527722 on ClinicalTrials.gov