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| Name | Class |
|---|---|
| Cook Endoscopy | INDUSTRY |
| University of North Carolina | OTHER |
| Johns Hopkins University | OTHER |
| Thoraxklinik-Heidelberg gGmbH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22-gauge Standard Needle | Active Comparator | Participants will have each node sampled starting with the standard 22G needle on the first pass followed by the ProCore 22G needle on the second pass (for a total of 8 passes) |
|
| 22-gauge ProCore Needle | Active Comparator | Participants will have each node sampled starting with the ProCore 22G on the first pass followed by the standard 22G needle on the second pass (for a total of 8 passes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22-gauge Standard Needle | Other | Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles. | Within two weeks from the day of the procedure | |
| Quality of tumor obtained (measured by cell block and ability to perform mutational analysis) | Within two weeks from the day of the procedure | |
| Quantity of tissue obtained (measured by number of unstructured fragments) | Within two weeks from the day of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nichole T Tanner, MD, M.S.C.R | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| Johns Hopkins University |
| OTHER |
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| 22-gauge ProCore Needle | Other | Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway. |
|
| 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 |