Prostate Cancer Clinical Trial
Official title:
A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Urology | Cartersville | Georgia |
Lead Sponsor | Collaborator |
---|---|
Uro-1 Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure Success | Percentage of tissue samples suitable for pathological review | 1 Day of the procedure | |
Primary | Adverse Events | Incidence and Severity of Adverse events associated with use of the biopsy needles | 1 Day of the procedure | |
Primary | Patient Pain During use of the biopsy needles | Pain measured with Likert Scale of 1 to 5 | 1 Day of the procedure | |
Secondary | Mean Tissue volume for each sample taken | Length and diameter of tissue samples for cubic centimeters of volume | 1 Day of the procedure |
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