CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
ExAblate MR Guided Focused Ultrasounddevice
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/NCT01657942
NCT01657942N/ACompleted
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Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

InSightec·interventional·Posted Aug 6, 2012·Updated Nov 13, 2024

In Brief

A clinical study evaluating ExAblate MR Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions. Completed, enrolled 101 participants across 9 sites.

Detailed Summary

The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocalized Intermediate Risk Prostate Lesions
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2012
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2019
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 13.9 years ago

Interventions

ExAblate MR Guided Focused Ultrasounddevice

ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.