ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    NeuroDx Development
Updated on 7 November 2020
Investigator
Ashley Simmons
Primary Contact
Children's National Medical Center (5.4 mi away) Contact
+9 other location

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.

Details
Treatment ShuntCheck-Micro-Pumper (SCMP), Imaging
Clinical Study IdentifierNCT01881711
SponsorNeuroDx Development
Last Modified on7 November 2020

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