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NCT05470127 · ClinicalTrials.gov registry record · NA
Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
A NA study of Prostate CA and Prostate Disease, sponsored by Uro-1 Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05470127: Recruiting NA study of Prostate CA and Prostate Disease, sponsored by Uro-1 Medical.
NCT05470127 is a NA study of Prostate CA and Prostate Disease that is actively recruiting participants, run by Uro-1 Medical. The registered enrollment target is 200 participants, above the 91-participant average among 4 other Prostate CA trials with a reported enrollment target (120% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05470127, a NA study of Prostate CA and Prostate Disease, is actively recruiting participants, sponsored by Uro-1 Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Percentage of tissue samples collected that are suitable for pathological review
Conditions Studied
Interventions
- DEVICE Prostate biopsy needle
Study Locations (1)
Georgia
- Georgia Urology - Cartersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT05470127 shows while recruiting
NCT05470127 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 91-participant average among 4 other Prostate CA trials with a reported enrollment target (120% higher).
The record links to 2 conditions, with Prostate CA appearing as the primary indexed condition, and to 1 intervention - of which Prostate biopsy needle is the first listed.
NCT05470127 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05470127 about?
NCT05470127 is a clinical study titled "Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters". 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 ...
What is the current status of trial NCT05470127?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2022-08-01. Estimated completion is 2025-12.
What conditions does trial NCT05470127 study?
This clinical trial studies the following conditions: Prostate CA, Prostate Disease.
What interventions are being tested in trial NCT05470127?
The interventions under investigation include: Prostate biopsy needle (DEVICE).
Who is sponsoring clinical trial NCT05470127?
This trial is sponsored by Uro-1 Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05470127 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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