Water Vapor Ablation for Prostate Cancer: Long-Term Registry
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorFrancis Medical Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Contraindications per the Vanquish IFU
Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Vanquish Therapy
DeviceThe 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.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: Vanquish Procedure Patients1 intervention
Trial outcomes
Primary outcomes
1
Primary Efficacy Outcome
Freedom from disease specific mortality.
Time frame
Through study completion, or up to 15 years.2
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov