ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | Any - 29 |
Updated: | 4/2/2016 |
Start Date: | May 2013 |
End Date: | September 2015 |
Contact: | Joseph R Madsen, MD |
Email: | Joseph.Madsen@childrens.harvard.edu |
Phone: | 617) 355-6005 |
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
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.
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.
Inclusion Criteria:
1. Males or females, older than 35 months and less than 20 years of age.
2. 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.
3. Possess an unambiguously identifiable chronically indwelling ventricular shunt which
crosses the clavicle.
4. Suspicion of shunt obstruction is great enough to warrant the performance of any
diagnostic test for this condition
5. Will be available for follow-up for up to 7 days
Exclusion Criteria:
1. Inability or unwillingness of the parent/guardian or alert subject to give informed
consent/assent (when appropriate) as required by the Institutional Review Board.
2. Presence of multiple shunts or known non-functioning shunts crossing the clavicle.
3. Evaluating staff rule out shunt obstruction on the basis of a physical/clinical
examination.
4. SCMP test would interfere with emergent subject care or if the subject is scheduled
to go the OR in short order.
5. Presence of an interfering open wound or edema over the shunt.
6. 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.
7. Any other condition that would preclude or bias the results of the study according to
the judgment of the investigator.
8. Judgment of the investigator that participation in the study will interfere with, or
be detrimental to, administration of optimal health-care to the subject.
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11
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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