Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
NCT ID: NCT00562302
Last Updated: 2013-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
339 participants
INTERVENTIONAL
2005-04-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Bio-Seal Group
Bio-Seal Plug Implanted
Bio-Seal Plug
Deployment of the Bio-Seal plug in needle track
Control Group
Control group with no intervention
No interventions assigned to this group
Interventions
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Bio-Seal Plug
Deployment of the Bio-Seal plug in needle track
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must be at least 18 years of age;
* The patient, or legal representative, must understand and provide written consent for the procedure;
* The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.
Exclusion Criteria
* Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
* Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.
* Patients who are uncooperative or cannot follow instructions.
* Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.
18 Years
ALL
No
Sponsors
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Angiotech Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rui Avelar, MD
Role: STUDY_DIRECTOR
Angiotech Pharmaceuticals
Locations
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Scottsdale Medical Imaging
Scottsdale, Arizona, United States
St. Josephs Radiology Limited
Tuscon, Arizona, United States
UCLA School of Medicine
Los Angeles, California, United States
Univerisity of California, San Diego
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Vascular and Interventional Radiology
New Haven, Connecticut, United States
Morton Plant Mease Health Care
Clearwater, Florida, United States
Florida Research Network
Gainesville, Florida, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
St. Louis Medical Center
St Louis, Missouri, United States
Univeristy of Cincinnati Medical Center
Cincinnati, Ohio, United States
St Lukes Hospital
Bethlehem, Pennsylvania, United States
Memorial Medical Center
Johnstown, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States
Evergreen Healthcare Diagnostic Imaging
Kirkland, Washington, United States
Sacred Heart Medical Center & Heart Institute of Spokane
Spokane, Washington, United States
Countries
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Other Identifiers
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BS-1053
Identifier Type: -
Identifier Source: org_study_id
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