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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VMCore Biopsy System | Experimental | The VMCore biopsy needle will used to collect up to 10 tissue samples. |
|
| Standard of Care Biopsy Needle | Active Comparator | The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VMCore Biopsy System | Device | Prostate Examine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | Percentage of tissue samples suitable for pathological review | 1 Day of the procedure |
| Adverse Events | Incidence and Severity of Adverse events associated with use of the biopsy needles | 1 Day of the procedure |
| Patient Pain During use of the biopsy needles | Pain measured with Likert Scale of 1 to 5 | 1 Day of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
Only males have a prostate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lawson, PhD | Contact | 5102061794 | drthomlawson@gmail.com | |
| Jack Snoke | Contact | 3365750434 | pjsnoke@uro1medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Lawson | Uro-1 Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Urology | Recruiting | Cartersville | Georgia | 30120 | United States |
No patient data will be shared among researchers. Tissue data may be shared
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Each subject will have biopsy performed with both the study needle and a standard of care needle
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| Standard of Care Biopsy Needle |
| Device |
Prostate Examine |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |