A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

Recruiting N/A Interventional Study
Benign Centrally-Located Intracranial Tumors
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
5 – 22
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
InSightec · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 do…
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