NCT04656678

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

A Study to Evaluate the Safety and Efficacy of Focal US Guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Locally Confined Low to Intermediate Risk Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, prospective, single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. All subjects will be treated and then followed up clinically for up to 24 months to evaluate any procedure or device related adverse events as well as to assess efficacy endpoints of the study. Additional data related to quality of life of treated subjects will also be collected

Conditions

• Prostate Cancer
• Prostate Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-25
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2020-12-07
• Last updated: 2024-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study