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The purpose of the registry is to evaluate real-world safety, efficacy, and patient reported outcomes among participants receiving Vanquish Water Vapor Ablation System therapy (Vanquish Therapy). This includes longitudinal assessment of patients who have received or will receive the therapy one or multiple times as part of routine clinical care and encompasses those who completed a company-sponsored Vanquish therapy study (as applicable).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanquish Procedure Patients | Patients that have completed or will complete a Vanquish therapy and plan to continue their routine clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanquish Therapy | Device | The Francis Medical, Inc. Vanquish Water Vapor Ablation Device ("Vanquish" or "Vanquish System") is a transurethral thermal water vapor ablation device. The Vanquish System is designed ablate prostate tissue, while minimizing side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Outcome | Freedom from disease specific mortality. | Through study completion, or up to 15 years. |
| Primary Safety Outcome | Rate of complications classified as Clavien-Dindo grades III-V and attributable to the Vanquish procedure and/or device over time.
| Through study completion, or up to 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be enrolled based on the inclusion/exclusion criteria listed. The Investigator(s) are responsible for determining if a patient is a candidate for therapy with the Vanquish System.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney Cartie | Contact | 6122866855 | scartie@francismedical.com | |
| Garrett Grenier | Contact | 763-453-9404 | ggrenier@francismedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Urology Place, Inc. | Recruiting | San Antonio | Texas | 78240 | United States |
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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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| Urology of Virginia | Recruiting | Virginia Beach | Virginia | 23462 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |