The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible.
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible. This is a feasibility study intended to collect data for use in the development of future studies. As such, no formal statistical hypothesis or hypothesis testing is proposed. The purpose of this study is to evaluate the safety and feasibility of managing benign brain tumor size using ExAblate 4000 treatment of progressing benign intracranial tumors which require clinical intervention in pediatric and young adult subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Focused ultrasound
Children's National Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGNicklaus Children's Hospital
Miami, Florida, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events Safety and Tolerability
Safety will be assessed by tabulation of treatment related adverse events. All adverse events at least possibly procedure related will also be examined in detail for patterns of occurrence.
Time frame: Post ExAblate Procedure through 12 Month Follow-up
Measurement of Tumor Volume
ExAblate procedure will demonstrate feasibility along with measurement of tumor volumes at follow-up as compared to the baseline MRI.
Time frame: Baseline through 12 Month Follow Up
Changes in the General Physical Exam
Any changes in physical examination performed by a physician.
Time frame: Baseline through 12 Month Follow Up
Changes in the Neurological Exam
Any changes in neurological examination performed by the neurologist/neurosurgeon.
Time frame: Baseline through 12 Month Follow Up
Confrontational Visual Field Testing
Changes in confrontational visual field testing performed by a physician
Time frame: Baseline through 3 Month Follow Up
Global Impression of Change-Clinician
Impression of change as the result of the treatment by a physician
Time frame: Day 1 through 12 Month Follow Up
Patient Global Impression of Change
Impression of change as the result of the treatment by the subject
Time frame: Day 1 through 12 Month Follow Up
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