Phase
Condition
Hemorrhage
Brain Injury
Stroke
Treatment
CerebroFlo™ EVD Catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject and/or legally authorized representative has reviewed the InstitutionalReview Board (IRB)-approved consent form, has been properly consented per theprotocol and has documented their consent to participate in the study by signing theIRB-approved consent form.
Subject is ≥ 18 years of age at the time of consent.
Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVHdue to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed withoutcomplication.
Subjects who require only one EVD Catheter at initial admission
Exclusion
Exclusion Criteria:
Subjects with a scalp infection present.
Subjects with uncorrectable coagulopathy due to prior administration ofanticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed.
Subjects known to have a bleeding diathesis.
Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma
Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVDCatheter(s) on post-placement CT scan.
Subject is pregnant
Study Design
Study Description
Connect with a study center
Loma Linda University Health
Loma Linda, California 92350
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
AdventHealth Orlando
Orlando, Florida 32803
United StatesSite Not Available
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Icahn School of Medicine at Mt. Sinai
New York, New York 10029
United StatesSite Not Available
Wright State University/Premier Health
Dayton, Ohio 45409
United StatesSite Not Available
Medical City Plano
Plano, Texas 75075
United StatesSite Not Available
University of Texas Health Science Center
San Antonio, Texas 78229
United StatesSite Not Available
University of Utah Health
Salt Lake City, Utah 84123
United StatesSite Not Available
Virginia Commonwealth University Department of Neurosurgery
Richmond, Virginia 23298
United StatesSite Not Available

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