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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
339
Deployment of the Bio-Seal plug in needle track
Scottsdale Medical Imaging
Scottsdale, Arizona, United States
St. Josephs Radiology Limited
Tuscon, Arizona, United States
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).
Time frame: 30 days
Incidence of Chest Tube Placement
A chest tube is the definitive initial treatment of a pneumothorax.
Time frame: 30 days
Time to Ambulation
Time frame: 30 days
Incidence of Hospital Admissions for Pneumothorax
Time frame: 30 day
Incidence of Adverse Events Related to the Procedure and Device Effects
Anticipated, device-related adverse events that were defined in the original protocol.
Time frame: 30 Day
Number of Participants With Additional Chest X-rays Needed
Time frame: 30 day
Participants Discharged Beyond Hospital's Standard of Care
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.
Time frame: 30-day
Incidence of Adverse Events
Any treatment emergent adverse events (not considered device related by the investigators).
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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
...and 8 more locations
Time frame: 30 days