Know Cancer

forgot password

A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence Rate of Treatment Success

Outcome Description:

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).

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Rui Avelar, MD

Investigator Role:

Study Director

Investigator Affiliation:

Angiotech Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

August 2008

Related Keywords:

  • Pneumothorax
  • lung biopsy
  • Pneumothorax



UCLA School of Medicine Los Angeles, California  900121973
Stanford University Medical Center Stanford, California  94305-5408
Rhode Island Hospital Providence, Rhode Island  02903
Baptist Memorial Hospital Memphis, Tennessee  38146
Morton Plant Mease Health Care Clearwater, Florida  33756
UMass Memorial Medical Center Worcester, Massachusetts  01655
University of Texas/MD Anderson Cancer Center Houston, Texas  77030
Scottsdale Medical Imaging Scottsdale, Arizona  85258
St. Josephs Radiology Limited Tuscon, Arizona  85711
Univerisity of California, San Diego San Diego, California  92103
Vascular and Interventional Radiology New Haven, Connecticut  208042
Florida Research Network Gainesville, Florida  32605
St. Louis Medical Center St. Louis, Missouri  63110
Univeristy of Cincinnati Medical Center Cincinnati, Ohio  45287
St Lukes Hospital Bethlehem, Pennsylvania  18015
Memorial Medical Center Johnstown, Pennsylvania  15905
Evergreen Healthcare Diagnostic Imaging Kirkland, Washington  98034
Sacred Heart Medical Center & Heart Institute of Spokane Spokane, Washington  99204