Vanquish® Water Vapor Ablation for PrOstate CanceR: Long-Term Registry
Summary
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).
Arms & interventions
- DeviceVanquish Therapy
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.
Outcome measures
Primary
Primary Efficacy Outcome
Freedom from disease specific mortality.
Time frame: 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. * Grade III: Complications requiring surgical intervention (IIIa: laparoscopic, IIIb: open). * Grade IV: Life-threatening complications (IVa: single organ failure, IVb: multi-organ failure). * Grade V: Death of a patient.
Time frame: Through study completion, or up to 15 years
Eligibility criteria
Study locations (2)
The Urology Place, Inc.
San Antonio, Texas, 78240
Urology of Virginia
Virginia Beach, Virginia, 23462