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| Sponsor: | Angiotech Pharmaceuticals |
|---|---|
| Information provided by: | Angiotech Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00562302 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumothorax |
Device: Bio-Seal Plug |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy |
| Enrollment: | 339 |
| Study Start Date: | April 2005 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bio-Seal Group
Bio-Seal Plug Implanted
|
Device: Bio-Seal Plug
Deployment of the Bio-Seal plug in needle track
Other Name: Bio-Seal™ Lung Biopsy Tract System
|
|
No Intervention: Control Group
Control group with no intervention
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Scottsdale Medical Imaging | |
| Scottsdale, Arizona, United States, 85258 | |
| St. Josephs Radiology Limited | |
| Tuscon, Arizona, United States, 85711 | |
| United States, California | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| Univerisity of California, San Diego | |
| San Diego, California, United States, 92103 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Vascular and Interventional Radiology | |
| New Haven, Connecticut, United States, 208042 | |
| United States, Florida | |
| Morton Plant Mease Health Care | |
| Clearwater, Florida, United States, 33756 | |
| Florida Research Network | |
| Gainesville, Florida, United States, 32605 | |
| United States, Massachusetts | |
| UMass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Missouri | |
| St. Louis Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Univeristy of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45287 | |
| United States, Pennsylvania | |
| St Lukes Hospital | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Memorial Medical Center | |
| Johnstown, Pennsylvania, United States, 15905 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| Baptist Memorial Hospital | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| University of Texas/MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Evergreen Healthcare Diagnostic Imaging | |
| Kirkland, Washington, United States, 98034 | |
| Sacred Heart Medical Center & Heart Institute of Spokane | |
| Spokane, Washington, United States, 99204 | |
| Study Director: | Rui Avelar, MD | Angiotech Pharmaceuticals |
More Information
| Responsible Party: | Dr. Rui Avelar/CMO, Angiotech Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00562302 History of Changes |
| Other Study ID Numbers: | BS-1053 |
| Study First Received: | November 20, 2007 |
| Last Updated: | July 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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lung biopsy |
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Pneumothorax Pleural Diseases Respiratory Tract Diseases |