CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled / 121 target
Drug / intervention
Irreversible Electroporationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04972097
NCT04972097N/ACompletedMonitor (2.4/mo)Completion was 22mo ago

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

Angiodynamics, Inc.·interventional·Posted Jul 22, 2021·Updated Jun 2, 2026

In Brief

A clinical study evaluating Irreversible Electroporation for Prostate Cancer. Completed, enrolled 121 participants across 17 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 22, 2021
Enrollment StartMar 29, 2022
Primary CompletionAug 14, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.9 years ago

Arms & Interventions

IRE Treatment Armexperimental

All patients enrolled in this trial will receive IRE treatment with the NanoKnife System

Device: Irreversible Electroporation

Interventions

Irreversible Electroporationdevice

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.