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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00562302
First received: November 20, 2007
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by Angiotech Pharmaceuticals:

Primary Outcome Measures:
  • Incidence Rate of Treatment Success [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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:
  • Incidence of Chest Tube Placement [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    A chest tube is the definitive initial treatment of a pneumothorax.

  • Time to Ambulation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of Hospital Admissions for Pneumothorax [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse Events Related to the Procedure and Device Effects [ Time Frame: 30 Day ] [ Designated as safety issue: Yes ]
    Anticipated, device-related adverse events that were defined in the original protocol.

  • Number of Participants With Additional Chest X-rays Needed [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Participants Discharged Beyond Hospital's Standard of Care [ Time Frame: 30-day ] [ Designated as safety issue: No ]
    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.

  • Incidence of Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Any treatment emergent adverse events (not considered device related by the investigators).


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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562302

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

No publications provided

Responsible Party: Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00562302     History of Changes
Other Study ID Numbers: BS-1053
Study First Received: November 20, 2007
Results First Received: February 4, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:
lung biopsy

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013