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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562302
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Information provided by (Responsible Party):
Angiotech Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumothorax Device: Bio-Seal Plug Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence Rate of Treatment Success [ Time Frame: 30 days ]
    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).

Secondary Outcome Measures :
  1. Incidence of Chest Tube Placement [ Time Frame: 30 days ]
    A chest tube is the definitive initial treatment of a pneumothorax.

  2. Time to Ambulation [ Time Frame: 30 days ]
  3. Incidence of Hospital Admissions for Pneumothorax [ Time Frame: 30 day ]
  4. Incidence of Adverse Events Related to the Procedure and Device Effects [ Time Frame: 30 Day ]
    Anticipated, device-related adverse events that were defined in the original protocol.

  5. Number of Participants With Additional Chest X-rays Needed [ Time Frame: 30 day ]
  6. Participants Discharged Beyond Hospital's Standard of Care [ Time Frame: 30-day ]
    Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital's standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.

  7. Incidence of Adverse Events [ Time Frame: 30 days ]
    Any treatment emergent adverse events (not considered device related by the investigators).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562302

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
Sponsors and Collaborators
Angiotech Pharmaceuticals
Study Director: Rui Avelar, MD Angiotech Pharmaceuticals

Responsible Party: Angiotech Pharmaceuticals Identifier: NCT00562302     History of Changes
Other Study ID Numbers: BS-1053
First Posted: November 22, 2007    Key Record Dates
Results First Posted: March 27, 2013
Last Update Posted: March 27, 2013
Last Verified: March 2013

Keywords provided by Angiotech Pharmaceuticals:
lung biopsy

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases