The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound
The purpose of this study is to compare the usefulness of two needles used for obtaining a lung tissue sample: (1) standard 22-gauge, and (2) ProCore 22-gauge. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful. The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
200
Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
University of Florida
Gainesville, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of North Carolina Medical School
Chapel Hill, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles.
Time frame: Within two weeks from the day of the procedure
Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)
Time frame: Within two weeks from the day of the procedure
Quantity of tissue obtained (measured by number of unstructured fragments)
Time frame: Within two weeks from the day of the procedure
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