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PHIL® Embolic System Pediatric IDE
Sponsor: Alejandro Berenstein
Summary
The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.
Official title: Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
Key Details
Gender
All
Age Range
Any - 21 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2019-04-16
Completion Date
2027-12
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
PHIL® device
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas
Locations (1)
Mount Sinai Hospital
New York, New York, United States