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Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

NCT04972097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-02-12

No results posted yet for this study

Summary

Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.

Conditions

Interventions

DEVICE

Irreversible Electroporation

IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Coleman, MD · Memorial Sloan Kettering Cancer Center

  • Arvin George, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2024-08-14
Completion
2024-08-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04972097 on ClinicalTrials.gov