PHIL® Embolic System Pediatric IDE

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Arterio-venous Fistula
Arteriovenous Fistula
Arteriovenous Malformations
Fistula
Intracranial Arteriovenous Malformations

Clinical Trial Details

NCT number	NCT03731000
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact	Sukaina Davdani
Phone	(212) 241-2524
Email	sukaina.davdani@mountsinai.org
Status	Recruiting
Phase	N/A
Start date	April 16, 2019
Completion date	December 2027

View Details

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