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This goal of this clinical trial is to determine if the Vanquish System can safely and effectively treat cancerous tissue in the prostate. Researchers will also determine the best treatment dose, monitor safety during and immediately after the procedure, and examine prostate tissue after surgical removal to confirm how well the treatment destroyed targeted tissue. Patients enrolled have been diagnosed with prostate cancer and will undergo treatment with the Vanquish System before their scheduled radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Vanquish System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water Vapor Ablation | Device | Water vapor ablation delivered transurethrally in patients undergoing a radical prostatectomy for prostate cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Characterization by Location and Thermal Damage | The primary efficacy endpoint is a lesion characterization from the Peri III Study vapor treatment as evaluated by TTC stain. Immediately following treatment and surgical extirpation, the prostate was examined for any external thermal injury followed by whole mount sectioning and staining using tetrazolium chloride (TTC). The whole mount sections were photographed before and after TTC staining. The sections and photographs were examined for ablation within all anatomic regions of the prostate and the ability to ablate to different regions and zones of the prostate. | Evaluated immediately post procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy Scale to Measure Visualization During Procedure | Visualization during the procedure is important to ensure proper placement of the needle. Ultrasound was evaluated for visualization and graded by operator. Visualization adequacy was assessed in real time by the physician using a categorical scale (adequate/somewhat adequate/inadequate), based on subjective evaluation of target and instrument visibility on the ultrasound image. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C&M Research S.A. | Panama City | Provincia de Panamá | 0801 | Panama |
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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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| From the beginning to the end of the treatment procedure. |
| Safety Measurements | Any procedure-related AEs were collected and reported through 30 days. | Through 30 days following procedure. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |