Prostate Cancer
Conditions
Brief summary
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.
Detailed description
This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.
Interventions
DEVICEStandard of Care Biopsy Needle
Prostate Examine
DEVICEVMCore Biopsy System
Prostate Examine
Sponsors
Uro-1 Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Each subject will have biopsy performed with both the study needle and a standard of care needle
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male * Scheduled for a prostate biopsy * Able and willing to provide verbal assessment of his condition 5 days post-procedure
Exclusion criteria
* Unable or unwilling to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 1 Day of the procedure | Percentage of tissue samples suitable for pathological review |
| Adverse Events | 1 Day of the procedure | Incidence and Severity of Adverse events associated with use of the biopsy needles |
| Patient Pain During use of the biopsy needles | 1 Day of the procedure | Pain measured with Likert Scale of 1 to 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Tissue volume for each sample taken | 1 Day of the procedure | Length and diameter of tissue samples for cubic centimeters of volume |
Countries
United States
Contacts
Primary ContactThomas Lawson, PhD
Backup ContactJack Snoke
Outcome results
None listed