Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure

Completed · Phase 3

Conditions studied: Pneumothorax

In brief

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

Key facts

Study ID

NCT00562302

Run by

Angiotech Pharmaceuticals

People needed

339

Starts

2005-04-01

Expected to finish

2008-08-01

Last updated by the study team

2013-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must meet all medical conditions for lung biopsy;
• 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.

You may not qualify if…

• Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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