RecruitingNot ApplicableNCT03731000

PHIL® Embolic System Pediatric IDE

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

Sponsor

Alejandro Berenstein

Enrollment

15 participants

Start Date

Apr 16, 2019

Study Type

INTERVENTIONAL

Conditions

Intracranial Arteriovenous Malformations Arterio-venous Fistula

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.

Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying PHIL® device for people with arterio-venous fistula and intracranial arteriovenous malformations. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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