NCT03731000

PHIL® Embolic System Pediatric IDE

Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Alejandro Berenstein · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arterio-venous Fistula
• Intracranial Arteriovenous Malformations

Interventions

Type	Name	Description
DEVICE	PHIL® device	Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Timeline

• Start date: 2019-04-16
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2018-11-05
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study