Phase
Condition
N/ATreatment
Ventriculoperitoneal Shunt
Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
Clinical Study ID
Ages 1-104 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Corrected age <104 weeks and 0 days, AND
Child is ≥ 37 weeks post menstrual age, AND
Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, whichapproximates "moderate ventriculomegaly"), and at least one of the following:
Head circumference >98th percentile for corrected age with either bulgingfontanelle or splayed sutures
Upgaze paresis/palsy (sundowning)
CSF leak
Papilledema
Tense pseudomeningocele or tense fluid along a track
Vomiting or irritability, with no other attributable cause
Bradycardias or apneas, with no other attributable cause
Intracranial pressure (ICP) monitoring showing persistent elevation of pressurewith or without plateau waves AND
- No prior history of shunt insertion or endoscopic third ventriculostomy (ETV)procedure (previous temporization devices and/or external ventricular drainspermissible)
Exclusion
Exclusion Criteria:
Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeksgestational age; OR
Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shuntdefined as:
Moderate to severe prepontine adhesions on steady state free precession (SSFP)or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes thefollowing sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE),CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX
Closure of one or both foramina of Monro
Thick floor of third ventricle (≥ 3mm)
Narrow third ventricle (<5mm)
Presence of scalp, bone, or ventricular lesions that make placement of ananterior shunt impracticable; OR
Underlying condition with a high chance of mortality within 12 months; OR
Hydrocephalus with loculated CSF compartments; OR
Peritoneal cavity not suitable for distal shunt placement; OR
Active CSF infection; OR
Hydranencephaly; OR
Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition tothe initial first-time permanent procedure for the treatment of hydrocephalus.
Study Design
Study Description
Connect with a study center
Alberta Children's Hospital
Calgary, Alberta T3B 6A8
CanadaActive - Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia V6H 3V4
CanadaActive - Recruiting
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Children's of Alabama
Birmingham, Alabama 35233
United StatesActive - Recruiting
Children's Hospital of Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06520
United StatesSite Not Available
Wolfson Children's Hospital
Jacksonville, Florida 32207
United StatesActive - Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida 32806
United StatesActive - Recruiting
Johns Hopkins Children's Center
Baltimore, Maryland 21287
United StatesActive - Recruiting
St. Louis Children's Hospital
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesActive - Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
The Pennsylvania State University
University Park, Pennsylvania 16802
United StatesSite Not Available
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United StatesActive - Recruiting
Texas Children's Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Primary Children's Hospital
Salt Lake City, Utah 84118
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23284
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
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