Prostate CA, Prostate Disease
Conditions
Keywords
Prostate CA, Needle biopsy
Brief 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.
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
DEVICEProstate biopsy needle
Prostate tissue biopsy with a biopsy needle
Sponsors
Uro-1 Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The two biopsy needle sets will be used in the same patient during the procedure.
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 1 Day of the procedure | Percentage of tissue samples collected that are suitable for pathological review |
| Core length of tissue in the sample | 1 Day of the procedure | Quantity of Tissue Samples Collected |
| weight of tissue in the sample | 1 Day of the procedure | Quantity of Tissue Samples Collected |
| Tissue Sample Preparation | 1 Day of the procedure | Time required to prepare the tissue samples for pathological review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use of the biopsy needle | 1 Day of the procedure | Utility of the biopsy needle measured with a Likert scale of 1 to 5 |
Countries
United States
Contacts
Primary ContactThomas Lawson, PhD
Backup ContactJack Snoke
Outcome results
None listed