ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
- Conditions
- Suspected CSF Shunt Obstruction
- Interventions
- Device: ImagingDevice: ShuntCheck-Micro-Pumper (SCMP)
- Registration Number
- NCT01881711
- Lead Sponsor
- NeuroDx Development
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imaging Alone Imaging 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. Imaging Rule for Low Risk Cases Imaging 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 SCMP plus Imaging ShuntCheck-Micro-Pumper (SCMP) 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. SCMP plus Imaging Imaging 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. SCMP plus Imaging in Uncertain Cases Imaging 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 SCMP Rule Out for Low Risk Cases ShuntCheck-Micro-Pumper (SCMP) 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 SCMP plus Imaging in Uncertain Cases ShuntCheck-Micro-Pumper (SCMP) 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 Imaging alone in Uncertain Cases Imaging 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
- Primary Outcome Measures
Name Time Method Diagnostic accuracy compared with clinical outcomes 7 days 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.
Positive Predictive Value (PPV) 7 days 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.
Negative Predictive Value (NPV) 7 days 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.
Safety 1 day To determine if any adverse events were caused by the device or procedure while using the study device.
- Secondary Outcome Measures
Name Time Method Rule Out for Low Risk Cases 7 days 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"
Increased PPV and NPV for Uncertain Cases 7 days To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation.
Trial Locations
- Locations (11)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Chicago Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
A I dePont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Stony Brook Medical Center
🇺🇸Stony Brook, New York, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas-Houston/Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States