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