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NCT03731000 · ClinicalTrials.gov registry record · NA

PHIL® Embolic System Pediatric IDE

A NA study of Intracranial Arteriovenous Malformations and Arterio-venous Fistula, sponsored by Alejandro Berenstein.

Recruiting
Registry status
NA
Development phase
15
Enrollment target
1
Study location

NCT03731000 is a NA study of Intracranial Arteriovenous Malformations and Arterio-venous Fistula that is actively recruiting participants, run by Alejandro Berenstein. The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT03731000, a NA study of Intracranial Arteriovenous Malformations and Arterio-venous Fistula, is actively recruiting participants, sponsored by Alejandro Berenstein.

RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
1
Study location

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.

Interventions

  • DEVICE PHIL® device

Study Locations (1)

New York

  • Mount Sinai Hospital - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-04-16
Est. Completion 2027-12
Phase NA

Sponsor

Alejandro Berenstein

1 total trials

What the Registry Record Tells You About NCT03731000

The ClinicalTrials.gov registry entry for NCT03731000 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alejandro Berenstein, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Intracranial Arteriovenous Malformations appearing as the primary indexed condition, and to 1 intervention - of which PHIL® device is the first listed.

NCT03731000 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03731000 about?

NCT03731000 is a clinical study titled "PHIL® Embolic System Pediatric IDE". 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 Humanit...

What is the current status of trial NCT03731000?

This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2019-04-16. Estimated completion is 2027-12.

What conditions does trial NCT03731000 study?

This clinical trial studies the following conditions: Intracranial Arteriovenous Malformations, Arterio-venous Fistula.

What interventions are being tested in trial NCT03731000?

The interventions under investigation include: PHIL® device (DEVICE).

Who is sponsoring clinical trial NCT03731000?

This trial is sponsored by Alejandro Berenstein, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03731000 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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