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Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

StatusRecruiting
PhaseNot applicable
Started2022-08-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 7, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.

Amendment record

Amended once since 2022-07-21. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2025-05-02
Amendment Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Conditions, Study Design, Contacts/Locations v1
2022-07-21
Original filing
Trial Details
NCT Number NCT05470127
Lead Sponsor Uro-1 Medical
Conditions Prostate Disease, Prostate CA
Enrollment 200 participants
Start Date 2022-08-01
Primary Completion 2025-10 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-07