Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue (PERI III)

April 24, 2026 updated by: Francis Medical Inc.

Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue (Peri III Study)

This goal of this clinical trial is to determine if the Vanquish System can safely and effectively treat cancerous tissue in the prostate. Researchers will also determine the best treatment dose, monitor safety during and immediately after the procedure, and examine prostate tissue after surgical removal to confirm how well the treatment destroyed targeted tissue. Patients enrolled have been diagnosed with prostate cancer and will undergo treatment with the Vanquish System before their scheduled radical prostatectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama, 0801
        • C&M Research S.A.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is 40 years or older
  • Subjects is diagnosed with clinically localized prostate cancer (Stage I (T1c) or Stage II (T2a, T2b, T2c tumor) prostate cancer) AND scheduled for a radical prostatectomy or cystoprostatectomy due to the presence of prostate cancer
  • Subject has a positive biopsy for prostate cancer with Gleason score of 8 (4+4) and below
  • Subject who provides written consent to participate in the study

Exclusion Criteria:

  • Subject with prostate biopsy performed within 42 days from date of prostatectomy.
  • Subject has a known allergy to nickel.
  • Subject who had previous rectal surgery (other than hemorrhoidectomy)
  • Subject with known history of rectal disease.
  • Subject currently participating in other premarket investigational studies.
  • Subject who had a previous TURP or prostatectomy.

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Vanquish System
Device: Water Vapor Ablation
Water vapor ablation delivered transurethrally in patients undergoing a radical prostatectomy for prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion Characterization by Location and Thermal Damage
Time Frame: Evaluated immediately post procedure.
The primary efficacy endpoint is a lesion characterization from the Peri III Study vapor treatment as evaluated by TTC stain. Immediately following treatment and surgical extirpation, the prostate was examined for any external thermal injury followed by whole mount sectioning and staining using tetrazolium chloride (TTC). The whole mount sections were photographed before and after TTC staining. The sections and photographs were examined for ablation within all anatomic regions of the prostate and the ability to ablate to different regions and zones of the prostate.
Evaluated immediately post procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy Scale to Measure Visualization During Procedure
Time Frame: From the beginning to the end of the treatment procedure.
Visualization during the procedure is important to ensure proper placement of the needle. Ultrasound was evaluated for visualization and graded by operator. Visualization adequacy was assessed in real time by the physician using a categorical scale (adequate/somewhat adequate/inadequate), based on subjective evaluation of target and instrument visibility on the ultrasound image.
From the beginning to the end of the treatment procedure.
Safety Measurements
Time Frame: Through 30 days following procedure.
Any procedure-related AEs were collected and reported through 30 days.
Through 30 days following procedure.

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)

November 14, 2022

Primary Completion (Actual)

August 11, 2023

Study Completion (Actual)

August 11, 2023

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3838-012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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