Last updated on May 2019

PHIL Embolic System Pediatric IDE

Brief description of study

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.

Detailed Study Description

Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL device.

Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.

Clinical Study Identifier: NCT03731000

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Mount Sinai Hospital

New York, NY United States
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Recruitment Status: Open

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