ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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An Operator-Blinded Study of the Efficacy of ShuntCheck-Micro-Pumper, a Non-Invasive Diagnostic Procedure, in Detecting Ventricular Shunt Patency or Occlusion and in Predicting Clinical Outcome in Children and Adolescents Presenting to Emergency Departments and Neurosurgery Clinics

Conditions
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Suspected CSF Shunt Obstruction

Intervention / Treatment
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* Device: ShuntCheck-Micro-Pumper (SCMP)
* Device: Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, older than 35 months and less than 20 years of age. Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required. Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle. Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition Will be available for follow-up for up to 7 days Exclusion Criteria: Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board. Presence of multiple shunts or known non-functioning shunts crossing the clavicle. Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination. SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order. Presence of an interfering open wound or edema over the shunt. Likelihood, in the judgment of the investigator, of the subject being lost to follow-up as a result of subject unavailability or clinical outcome being unobtainable. Any other condition that would preclude or bias the results of the study according to the judgment of the investigator. Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.

Ages Eligible for Study
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Minimum Age: 35 Months
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCMP plus Imaging<br>SCMP plus Imaging 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. | Device: ShuntCheck-Micro-Pumper (SCMP)<br>* 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.<br>Device: Imaging<br>* Imaging of ventricle size<br>* Other names: MRI;|
| Active Comparator: Imaging Alone<br>Imaging alone 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. | Device: Imaging<br>* Imaging of ventricle size<br>* Other names: MRI;|
| Experimental: SCMP Rule Out for Low Risk Cases<br>SCMP results in patients judged by the physician to be Unlikely to require shunt surgery 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 - to determine Negative Predictive Value in ruling out shunt malfunction | Device: ShuntCheck-Micro-Pumper (SCMP)<br>* 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.<br>|
| Active Comparator: Imaging Rule for Low Risk Cases<br>Imaging results in patients judged by the physician to be Unlikely to require shunt surgery 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 - to determine Negative Predictive Value in ruling out shunt malfunction | Device: Imaging<br>* Imaging of ventricle size<br>* Other names: MRI;|
| Experimental: SCMP plus Imaging in Uncertain Cases<br>SCMP plus imaging results in patients who are admitted for observation results in patients judged by the physician to be Unlikely to require shunt surgery 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 - to determine Positive and Negative Predictive Value | Device: ShuntCheck-Micro-Pumper (SCMP)<br>* 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.<br>Device: Imaging<br>* Imaging of ventricle size<br>* Other names: MRI;|
| Active Comparator: Imaging alone in Uncertain Cases<br>Imaging results in patients who are admitted for observation results in patients judged by the physician to be Unlikely to require shunt surgery 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 - to determine Positive and Negative Predictive Value | Device: Imaging<br>* Imaging of ventricle size<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 7 days | 
| Safety | To determine if any adverse events were caused by the device or procedure while using the study device. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrocephalus, CSF shunt, shunt malfunction, shunt obstruction, ShuntCheck, ShuntCheck-Micro-Pumper