PHIL® Embolic System Pediatric IDE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorAlejandro Berenstein
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 Embolic System as a HUD in June 2016.
Eligibility criteria
Qualifiers
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 written informed consent prior to initiation of any study procedure
Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.
Disqualifiers
Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
Female subject is currently pregnant.
Trial design
Treatments tested in this trial
- PHIL® device
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Alejandro Berenstein
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov