A Feasibility Safety Study Using the ExAblate 4000 System in the Management of Benign Centrally-Located Intracranial Tumors Which Require Clinical Intervention in Pediatric and Young Adult Subjects
InSightec
Summary
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.
Description
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 evalua…
Eligibility
- Age range
- 5–22 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk * Minimum head circumference will be 49cm * Skull Density Ratio (SDR) should be ≥0.35 * Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records * Subjects and/or parent(s)/legal representative can provide accurate seizure diary log for the 30 days prior to FUS treatment and for the duration of the study Exclusion Criteria: * Subjects w…
Interventions
- DeviceExAblate 4000 System
Focused ultrasound
Locations (3)
- Children's National Medical CenterWashington D.C., District of Columbia
- Nicklaus Children's HospitalMiami, Florida
- Texas Children's HospitalHouston, Texas