Clinical trialNCT03731000RecruitingInterventional

PHIL® Embolic System Pediatric IDE

SponsorAlejandro BerensteinEnrollment15Arterio-venous FistulaIntracranial Arteriovenous Malformations

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alejandro Berenstein, MD
Icahn School of Medicine at Mount Sinai
Principal Investigator
clinicaltrials.gov ↗
Tomoyoshi Shigematsu, MD, PhD
Icahn School of Medicine at Mount Sinai
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Mount Sinai Hospital
New York, New York, United States
Tomoyoshi Shigematsu
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 16 Apr 2019
Primary completion: 31 Dec 2027
Completion: 31 Dec 2027
Last update posted: 27 Mar 2026
Registered enrollment: 15
Registry id: NCT03731000

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.