Evaluation of SureCore Plus Biopsy System
NCT06550960 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-08-13
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.
Conditions
- BPH
Interventions
- 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
Sponsors & Collaborators
-
Uro-1 Medical
lead INDUSTRY
Principal Investigators
-
Jeffrey Proctor, MD · Georgia Urology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-05
- Primary Completion
- 2024-12-31
- Completion
- 2025-02-01
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