Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2018-08-24
2022-12-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dAVF treatment
PHIL® Liquid Embolic System
PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Interventions
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PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Eligibility Criteria
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Inclusion Criteria
* Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
* Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
* Subject has an intracranial dAVF
Exclusion Criteria
* Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
* Subject has known allergies to dimethylsulfoxide, iodine.
* Subject is currently participating in another clinical study
* Female subject is currently pregnant.
* Subject has co-morbid conditions that may limit survival to less than 24 months.
22 Years
80 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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J Mocco, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai
Alan Boulos, MD
Role: PRINCIPAL_INVESTIGATOR
Albany Medical College
Locations
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Albany Medical Center
Albany, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CL11005
Identifier Type: -
Identifier Source: org_study_id