Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer

NCT04656678 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-02

No results posted yet for this study

Summary

The purpose of this research study is to determine the safety and feasibility of using the UroNav software and DynaCAD software for planning and treating prostate cancer as an add on to the already approved workflow of using ultrasound only during the cryoablation of the prostate. The software application may aid doctors in locating a prior biopsy proven cancer location from the UroNav biopsy that patients previously had and then use that information to guide the treatment.

Conditions

Interventions

DEVICE

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY
  • Northwell Health

    lead OTHER

Principal Investigators

  • Ardeshir Rastinehad, DO · Northwell Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2025-10-30
Completion
2025-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04656678 on ClinicalTrials.gov