Phase
Condition
N/ATreatment
FlowSense
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
At least one existing ventricular CSF shunt, functional or non-functional (includingan adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheterdisconnection or fracture, distal catheter fragment left in place during shuntsurgery, or indication that the shunt is otherwise non-functional), with a region ofoverlying intact skin appropriate in size for application of the study device
If more than one distal shunt catheter is present, at least one distal shuntcatheter is at least 2 cm away from any other distal shunt catheter in the devicemeasurement region
Signed informed consent by subject or a parent, legal guardian, health care agent,or surrogate decision maker (according to local statutes)
Signed medical records release by subject or a parent, legal guardian, health careagent, or surrogate decision maker (according to local statutes)
Verbal assent by minors 7 years of age and older who are able to understand thestudy and communicate their decision
Exclusion
Exclusion criteria:
Presence of an interfering open wound or edema in the FlowSense device measurementarea
Patient-reported history of serious adverse skin reactions to silicone-basedadhesives
Use of the study device would interfere with standard patient care, or emergencysurgery that cannot be delayed, or participation in the study will interfere with,or be detrimental to, administration of optimal healthcare to the subject
Participation in any other investigational procedural, pharmaceutical, and/or devicestudy that may influence the collection of valid data under this study
Study Design
Connect with a study center
CHOC Commerce Tower
Orange, California 92868
United StatesSite Not Available
Cedars-Sinai Accelerator
West Hollywood, California 90048
United StatesSite Not Available
Tampa Marriott Water Street
Tampa, Florida 33602
United StatesSite Not Available
MATTER
Chicago, Illinois 60611
United StatesSite Not Available
Industrious
Evanston, Illinois 60201
United StatesSite Not Available
Northwest Special Recreation Association
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Texas Medical Center Innovation
Houston, Texas 77021
United StatesSite Not Available
Industrious
Seattle, Washington 98015
United StatesSite Not Available
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