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Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

NCT01657942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2024-11-13

Study results available
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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.

Conditions

  • Localized Intermediate Risk Prostate Lesions

Interventions

DEVICE

ExAblate MR Guided Focused Ultrasound

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

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Behfar Ehdaie, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-10-31
Completion
2021-05-31

Countries

  • United States

Study Locations

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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 NCT01657942 on ClinicalTrials.gov