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PHIL® Embolic System Pediatric IDE

NCT03731000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Arterio-venous Fistula
  • Intracranial Arteriovenous Malformations

Interventions

DEVICE

PHIL® device

Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Sponsors & Collaborators

  • Alejandro Berenstein

    lead OTHER

Principal Investigators

  • Alejandro Berenstein, MD · Icahn School of Medicine at Mount Sinai

  • Tomoyoshi Shigematsu, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731000 on ClinicalTrials.gov