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Embolization Agent

PHIL® Embolic System for Arteriovenous Malformations

N/A
Recruiting
Led By Johanna Fifi, MD
Research Sponsored by Alejandro Berenstein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is <22 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is being done to collect data on the safety and effectiveness of the PHIL Embolic System in treating DAVFs.

Who is the study for?
This trial is for children under 22 with intracranial dural arteriovenous fistulas (dAVFs) suitable for embolization using the PHIL® device. They must have consent from a legal representative, be able to follow study procedures, and not weigh less than 2.5kg. Those with severe health risks, allergies to certain substances like DMSO or iodine, pregnant females, or those with life-threatening illnesses other than dAVFs cannot participate.Check my eligibility
What is being tested?
The PHIL® Embolic System is being tested for safety and potential benefits in treating intracranial dural arteriovenous fistulas in pediatric patients. This system has been approved by the FDA as a Humanitarian Use Device and this study aims to gather more data on its effectiveness.See study design
What are the potential side effects?
While specific side effects of the PHIL® Embolic System are not detailed here, similar devices may cause complications such as inflammation at the treatment site, allergic reactions to components of the device or procedure-related issues like bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 22 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with angiographic occlusion
Proportion of participants with neurological death or major ipsilateral stroke
Secondary outcome measures
Dosage of Radiation exposure
Incidence of angiographic cure
Incidence of cranial neuropathy
+13 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PHIL® deviceExperimental Treatment1 Intervention
Using device

Find a Location

Who is running the clinical trial?

Alejandro BerensteinLead Sponsor
Johanna Fifi, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
841 Total Patients Enrolled
Alejandro Berenstein, MD5.04 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai

Media Library

PHIL® Embolic System (Embolization Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03731000 — N/A
Intracranial Arteriovenous Malformations Research Study Groups: PHIL® device
Intracranial Arteriovenous Malformations Clinical Trial 2023: PHIL® Embolic System Highlights & Side Effects. Trial Name: NCT03731000 — N/A
PHIL® Embolic System (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03731000 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PHIL® Embolic System Pediatric IDE
Alejandro Berenstein 2019. "PHIL® Embolic System Pediatric IDE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03731000.
~6 spots leftby Dec 2027
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