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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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.
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
Incidence and severity of device/procedure-related complications following treatment
Safety will be evaluated by incidence and severity of device/procedure-related complications following treatment. Adverse events will be recorded and categorized according to severity and relationship to the biopsy procedure, the Exablate procedure, or to the Exablate device. They will be classified based on body system, severity, and frequency.
Time frame: 12 months
Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area.
Effectiveness will be evaluated by targeted lesion control based on biopsy results. Proportions of treated subjects reporting negative Gleason 7 biopsy within the treatment area and/or MRI verification of index lesion(s) ablation. PSA results and validated subject-reported questionnaires will be summarized.
Time frame: 6 months
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States