Actively Recruiting
PHIL® Embolic System Pediatric IDE
Led by Alejandro Berenstein · Updated on 2026-03-27
15
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PHIL® Embolic System Pediatric IDE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is under 22 years of age
- Participant and legal guardian are willing and able to follow all study procedures and follow-up visits
- Legal guardian has signed informed consent before any study procedures
- Participant has an intracranial dural arteriovenous fistula suitable for treatment with PHIL or has been previously treated with other embolic materials for dAVF
You will not qualify if you...
- Participant has an intracranial mass or is receiving radiation therapy for head or neck cancers
- Known allergies to DMSO, iodine, or heparin
- History of life-threatening allergy to contrast media unless managed successfully
- Female participant is currently pregnant
- Presence of acute or chronic life-threatening illness other than the neurological disease being treated, including malignancy or severe autoimmune disease
- Severe or advanced medical conditions increasing anesthesia or surgical risk
- Active infection at treatment time
- History of bleeding disorders, INR over 1.5, or refusal of blood transfusions
- Participant weighs 2.5 kg or less
- Severe blood vessel calcification or tortuosity preventing safe catheter access
- Contraindication to DSA, CT scan, or MRI/MRA imaging
- History of intracranial vasospasm not responding to medical therapy
- Extra-cranial or parent vessel stenosis greater than 50% near the lesion
- Risk for contrast-induced kidney injury or nephrogenic systemic fibrosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Sukaina Davdani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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