PHIL® Embolic System Pediatric IDE

Part of paid clinical trials in New York, New York.

Sponsor: Alejandro Berenstein
Study ID: NCT03731000
Status: Recruiting

Apply to this trial

Conditions

Arterio-venous Fistula
Intracranial Arteriovenous Malformations

Eligibility Criteria

Sex: ALL
Age: N/A - 21 Years
Healthy Volunteers: Not accepted

Interventions

PHIL® device — DEVICE
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Study Details

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.

Key Dates

Start date: Apr 16, 2019
Status verified: Mar 2026
Primary completion: Dec 31, 2027
Completion: Dec 31, 2027

Study Design

Enrollment: 15 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: PHIL® device
Using device

Primary Outcome Measure

Proportion of participants with neurological death or major ipsilateral stroke [ Time Frame: 12 months ]

Central Contacts

Sukaina Davdani
(212) 241-2524
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Mount Sinai Hospital	New York	New York	10029	Tomoyoshi Shigematsu (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site

Mount Sinai Hospital· New York, NY