Evaluation of SureCore Plus Biopsy System
- Conditions
- BPH
- Interventions
- Device: Evaluation of two biopsy systems
- Registration Number
- NCT06550960
- Lead Sponsor
- Uro-1 Medical
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 30
- Patient has BPH requiring a prostate biopsy
- Able and willing to provide consent
- Active infection
- Subject participating in an other device study of the prostate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SureCore Plus biopsy needle Evaluation of two biopsy systems Prostate biopsy of subject with BPH with a SureCore biopsy needle Standard of Care biopsy needle Evaluation of two biopsy systems Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle
- Primary Outcome Measures
Name Time Method Procedure success During the procedure \> 3 mm/cc of tissue collected in each biopsy
Quality of biopsy tissue During the procedure Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.
- Secondary Outcome Measures
Name Time Method Performance of the study device During the procedure Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome.