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RECRUITING NA

PHIL® Embolic System Pediatric IDE

NCT03731000 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03731000

The ClinicalTrials.gov registry entry for NCT03731000 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03731000 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03731000?

The interventions under investigation include: PHIL® device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03731000?

This trial is sponsored by Alejandro Berenstein, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial