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The purpose of this research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. The medical device delivers thermal energy in the form of water vapor to the prostate tissue through the urethra. Previous research has shown successful prostate tissue ablation. Additional research may help show successful ablation of the prostate tissue where cancer is located.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poseidon System Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poseidon System | Device | Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients with Intermediate Risk Localized Prostate Cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Serious device related adverse events | 180-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled | Up to 1 Years | |
| Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC) | 180-day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Urology | Baltimore | Maryland | 21204 | United States | ||
| University of Minnesota |
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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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| Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF) | 180-day follow-up |
| Changes from baseline in the International Prostate Cancer Symptom Score (IPSS) | 180-day follow-up |
| Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD) | 180-day follow-up |
| Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy | 180-day follow-up |
| Participants evaluated for biopsy negative on the treated side | 180-day follow-up |
| Changes from baseline with the PSA (Prostate Specific Antigen) | Up to 1 Year |
| Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging) | 180-day follow-up |
| Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy | 180-day follow-up |
| Participants evaluated for biopsy negative on the contralateral side | 180-day follow-up |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Minnesota Urology | Woodbury | Minnesota | 55125 | United States |
| Bon Secours/Good Samaritan Hospital | New York | New York | 10901 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |