Water Vapor Ablation for Prostate Cancer: Long-Term Registry (VAPOR-LTR)

June 10, 2026 updated by: Francis Medical Inc.

Vanquish® Water Vapor Ablation for PrOstate CanceR: Long-Term Registry

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • The Urology Place, Inc.
        • Principal Investigator:
          • Naveen Kella, MD
        • Contact:
        • Sub-Investigator:
          • Savannah Eggerss, PA
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia
        • Principal Investigator:
          • Robert Given, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vanquish Procedure Patients
Patients that have completed or will complete a Vanquish therapy and plan to continue their routine clinical care.
Device: Vanquish 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Outcome
Time Frame: Through study completion, or up to 15 years.
Freedom from disease specific mortality.
Through study completion, or up to 15 years.
Primary Safety Outcome
Time Frame: 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.
Through study completion, or up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francis Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2026

Primary Completion (Estimated)

April 30, 2041

Study Completion (Estimated)

July 31, 2041

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5600-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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