Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
400
ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.
Imaging of ventricle size
A I dePont Hospital for Children
Wilmington, Delaware, United States
RECRUITINGChildren's National Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Chicago Comer Children's Hospital
Chicago, Illinois, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGStony Brook Medical Center
Stony Brook, New York, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGChildren's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGRhode Island Hospital
Providence, Rhode Island, United States
RECRUITING...and 1 more locations
Diagnostic accuracy compared with clinical outcomes
SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Time frame: 7 days
Positive Predictive Value (PPV)
Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone.
Time frame: 7 days
Negative Predictive Value (NPV)
Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone.
Time frame: 7 days
Safety
To determine if any adverse events were caused by the device or procedure while using the study device.
Time frame: 1 day
Rule Out for Low Risk Cases
To demonstrate that SCMP plus Physician's judgment is comparable to Physician's judgment plus imaging in ruling out shunt malfunction in patients judged to be "Unlikely to require shunt surgery"
Time frame: 7 days
Increased PPV and NPV for Uncertain Cases
To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation.
Time frame: 7 days
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