Continued Access to Eval Focal MR-Guided Focused Ultrasound Tx in Intermediate Risk Prostate Lesions

Trial ID or NCT#

NCT03998657

Status

not recruiting iconNOT RECRUITING

Purpose

This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.

Official Title

A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

Eligibility Criteria

Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

Investigator(s)

Geoffrey A Sonn
Geoffrey A Sonn
Urologic oncologist, Urologist, Urologic specialist, Genitourinary specialist, Urologic surgeon
Associate Professor of Urology and, by courtesy, of Radiology (Body MRI)

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Contact

Ned U. Realiza
650-498-8496