A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy
This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients
will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a
lung biopsy per standard hospital protocol. This study is designed to demonstrate safety
and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung
biopsy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Incidence Rate of Treatment Success
Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).
30 days
Yes
Rui Avelar, MD
Study Director
Angiotech Pharmaceuticals
United States: Food and Drug Administration
BS-1053
NCT00562302
April 2005
August 2008
Name | Location |
---|---|
UCLA School of Medicine | Los Angeles, California 900121973 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Baptist Memorial Hospital | Memphis, Tennessee 38146 |
Morton Plant Mease Health Care | Clearwater, Florida 33756 |
UMass Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Texas/MD Anderson Cancer Center | Houston, Texas 77030 |
Scottsdale Medical Imaging | Scottsdale, Arizona 85258 |
St. Josephs Radiology Limited | Tuscon, Arizona 85711 |
Univerisity of California, San Diego | San Diego, California 92103 |
Vascular and Interventional Radiology | New Haven, Connecticut 208042 |
Florida Research Network | Gainesville, Florida 32605 |
St. Louis Medical Center | St. Louis, Missouri 63110 |
Univeristy of Cincinnati Medical Center | Cincinnati, Ohio 45287 |
St Lukes Hospital | Bethlehem, Pennsylvania 18015 |
Memorial Medical Center | Johnstown, Pennsylvania 15905 |
Evergreen Healthcare Diagnostic Imaging | Kirkland, Washington 98034 |
Sacred Heart Medical Center & Heart Institute of Spokane | Spokane, Washington 99204 |