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| Name | Class |
|---|---|
| NuView Diagnostics | UNKNOWN |
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This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer (PCa) | Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. |
| |
| Benign Prostatic Hypertrophy (BPH) | comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). |
| |
| Bladder/kidney stone | Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NV-VPAC1 PCa Urine Diagnostic Test | Diagnostic Test | The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of association of the presence of orange fluorescent positive cells shed in voided urine and lack of association of orange fluorescent positive cells in men diagnosed with BPH or in individuals with bladder/kidney stones | Degree of association of the presence of orange fluorescent positive cells shed in voided urine of men with biopsy-proven PCa and lack of association of orange fluorescent positive cells in men diagnosed with BPH or in individuals with bladder/kidney stones | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association between PSA levels and NV-VPAC1 test results. | 6 months |
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Subjects with prostate cancer
Inclusion Criteria:
Exclusion Criteria:
Subjects with benign prostatic hypertrophy
Inclusion Criteria:
Exclusion Criteria:
Subjects with bladder/kidney stones
Inclusion Criteria:
Exclusion Criteria:
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Patients with biopsy-confirmed prostate cancer, patients with BPH, and patients with bladder/kidney stones
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| Name | Affiliation | Role |
|---|---|---|
| Jay Bishoff, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
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urine specimens
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| D001744 | Urinary Bladder Calculi |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D014545 | Urinary Calculi |
| D052878 | Urolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
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