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This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.
Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SureCore Plus biopsy needle | Experimental | Prostate biopsy of subject with BPH with a SureCore biopsy needle |
|
| Standard of Care biopsy needle | Active Comparator | Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of two biopsy systems | Device | Each subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success | > 3 mm/cc of tissue collected in each biopsy | During the procedure |
| Quality of biopsy tissue | Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the study device | Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome. | During the procedure |
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Inclusion Criteria:
Exclusion Criteria:
This is biopsy of the prostate. Only males have a prostate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Proctor, MD | Contact | 770 607 1893 | jproctor@georgiaurology.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Proctor, MD | Georgia Urology | Principal Investigator |
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Two-arm study of study biopsy needle and standard of care biopsy needle
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