Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy
1 other identifier
interventional
339
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2005
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
March 27, 2013
CompletedMarch 27, 2013
March 1, 2013
3.2 years
November 20, 2007
February 4, 2013
March 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Treatment Success
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).
30 days
Secondary Outcomes (7)
Incidence of Chest Tube Placement
30 days
Time to Ambulation
30 days
Incidence of Hospital Admissions for Pneumothorax
30 day
Incidence of Adverse Events Related to the Procedure and Device Effects
30 Day
Number of Participants With Additional Chest X-rays Needed
30 day
- +2 more secondary outcomes
Study Arms (2)
Bio-Seal Group
EXPERIMENTALBio-Seal Plug Implanted
Control Group
NO INTERVENTIONControl group with no intervention
Interventions
Deployment of the Bio-Seal plug in needle track
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Scottsdale Medical Imaging
Scottsdale, Arizona, 85258, United States
St. Josephs Radiology Limited
Tuscon, Arizona, 85711, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Univerisity of California, San Diego
San Diego, California, 92103, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Vascular and Interventional Radiology
New Haven, Connecticut, 208042, United States
Morton Plant Mease Health Care
Clearwater, Florida, 33756, United States
Florida Research Network
Gainesville, Florida, 32605, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
St. Louis Medical Center
St Louis, Missouri, 63110, United States
Univeristy of Cincinnati Medical Center
Cincinnati, Ohio, 45287, United States
St Lukes Hospital
Bethlehem, Pennsylvania, 18015, United States
Memorial Medical Center
Johnstown, Pennsylvania, 15905, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
University of Texas/MD Anderson Cancer Center
Houston, Texas, 77030, United States
Evergreen Healthcare Diagnostic Imaging
Kirkland, Washington, 98034, United States
Sacred Heart Medical Center & Heart Institute of Spokane
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Doyle
- Organization
- Angiotech
Study Officials
- STUDY DIRECTOR
Rui Avelar, MD
Angiotech Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 22, 2007
Study Start
April 1, 2005
Primary Completion
June 1, 2008
Study Completion
August 1, 2008
Last Updated
March 27, 2013
Results First Posted
March 27, 2013
Record last verified: 2013-03