Status:
UNKNOWN
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
Lead Sponsor:
NeuroDx Development
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Suspected CSF Shunt Obstruction
Eligibility:
All Genders
35-29 years
Phase:
PHASE4
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 pediatri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01881711
Start Date
May 1 2013
End Date
September 1 2015
Last Update
June 23 2015
Active Locations (11)
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1
A I dePont Hospital for Children
Wilmington, Delaware, United States, 19803
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States, 60637
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287