Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prostate biopsy needle.
- Who it may be relevant to
- Registry conditions: Prostate Disease, Prostate CA. Basic parameters: 18 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.
Interventions
- Device Prostate biopsy needle
Prostate tissue biopsy with a biopsy needle
Primary outcome measures
- Procedure Success [Time frame: 1 Day of the procedure]
- Core length of tissue in the sample [Time frame: 1 Day of the procedure]
- weight of tissue in the sample [Time frame: 1 Day of the procedure]
- Tissue Sample Preparation [Time frame: 1 Day of the procedure]
Secondary outcome measures (1)
- Ease of use of the biopsy needle [Time frame: 1 Day of the procedure]
Eligibility criteria
Inclusion criteria
- Adult male scheduled for prostate biopsy
- Able to provide informed consent
- Able and willing to provide verbal assessment of his condition 5 days post-procedure
Exclusion criteria
- Unwilling to provide consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Georgia Urology — Cartersville
Identifiers
NCT: NCT05470127 · SUREcore v. SOC