PHIL® Embolic System Pediatric IDE
Recruiting
N/A
Interventional Study
Arterio-venous Fistula
Intracranial Arteriovenous Malformations
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 21
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Alejandro Berenstein · Other
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About This Trial
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 Emb…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject is \<22 years of age
* Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
* Subject's legally authorized representative(s) must sign and date an IRB approved wri…
Contacts