ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study (NCT01881711) | Clinical Trial Compass
UnknownPhase 4
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
United States400 participantsStarted 2013-05
Plain-language 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.
Who can participate
Age range35 Months – 29 Years
SexALL
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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.
What they're measuring
1
Diagnostic accuracy compared with clinical outcomes
✕. 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.