An interventional study of Evaluation of two biopsy systems in BPH, sponsored by Uro-1 Medical. Not yet recruiting. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Uro-1 Medical · Not applicable, Interventional, and Diagnostic
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.
Uro-1 Medical is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prostate biopsy of subject with BPH with a SureCore biopsy needle
Device: Evaluation of two biopsy systems
Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle
Device: Evaluation of two biopsy systems
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
Procedure success
\> 3 mm/cc of tissue collected in each biopsy
Time frame: 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.
Time frame: During the procedure
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.
Time frame: During the procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Uro-1 Medical