A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- InSightec
- Study ID
- NCT03028246
- Status
- Recruiting
Conditions
- Benign Centrally-Located Intracranial Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 22 Years
- Healthy Volunteers
- Not accepted
Interventions
- ExAblate 4000 System — DEVICEFocused ultrasound
Study Details
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.
Key Dates
- Start date
- Feb 28, 2017
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ExAblate 4000 SystemMR-Guided Focused Ultrasound
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability [ Time Frame: Post ExAblate Procedure through 12 Month Follow-up ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | Robert Keating (PRINCIPAL_INVESTIGATOR) Roger Packer (SUB_INVESTIGATOR) |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | John Ragheb, MD (PRINCIPAL_INVESTIGATOR) Marytery Fajardo, MD (SUB_INVESTIGATOR) Matt Lallas, MD (SUB_INVESTIGATOR) Pat Dean, ARNP (SUB_INVESTIGATOR) |
| Texas Children's Hospital | Houston | Texas | 77030 | Daniel Curry, MD (PRINCIPAL_INVESTIGATOR) Irfan Ali, MD (SUB_INVESTIGATOR) |