Status:
COMPLETED
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lung Biopsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air le...
Detailed Description
This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of t...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Referred for CT guided biopsy of lung lesion
- Target lesion of any size
- Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
- Skin thickness ≤7 cm (from skin to pleura)
- Needle path without transgression of pleural fissure bleb, or bulla is possible
- Coaxial biopsy technique using Angiotech 19-Gauge introducer needle
- Needle length ≤15
Exclusion
- Passage through non-aerated lung or tissue
- More than 1 biopsy on the same side requiring more than 1 pleural puncture
- History of prior ipsilateral lung interventions including:
- Chest tube placement
- Surgery
- Pleurodesis
- Radiation treatment
Key Trial Info
Start Date :
August 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2023
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT02224924
Start Date
August 21 2014
End Date
January 11 2023
Last Update
January 30 2024
Active Locations (2)
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1
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065