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ACTIVE NOT RECRUITING
NCT03998657
NA

Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

Sponsor: InSightec

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2019-12-19

Completion Date

2026-12-30

Last Updated

2025-05-01

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Exablate Prostate Treatment

The Exablate system is a non-invasive thermal ablation device that is being used to ablate tissue. The system combines a focused ultrasound surgery (FUS) delivery system and MRI scanner.

Locations (5)

Stanford University School of Medicine

Stanford, California, United States

Sperling Prostate Center

Delray Beach, Florida, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States