Prostate Cancer
Conditions
Brief 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).
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.
Sponsors
Francis Medical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Candidate for Vanquish therapy per physician discretion or participant has completed a company-sponsored Vanquish therapy study. * Participant is willing and able to provide written informed consent.
Exclusion criteria
* Contraindications per the Vanquish IFU * Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Outcome | Through study completion, or up to 15 years. | Freedom from disease specific mortality. |
| Primary Safety Outcome | Through study completion, or up to 15 years | 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. |
Countries
United States
Contacts
CONTACTSydney Cartie
CONTACTGarrett Grenier
Outcome results
None listed