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Clinical trialNCT01881711UnknownPhase 4Interventional

ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

SponsorNeuroDx DevelopmentEnrollment400Suspected CSF Shunt Obstruction
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • A I Depont Hospital for Children

    Wilmington, Delaware, United States

    Jonathan E Bennett, MDJoseph H Piatt, MD
    Recruiting
  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

    James Chamberlain, MDRobert F Keating, MD
    Recruiting
  • University of Chicago Comer Children'S Hospital

    Chicago, Illinois, United States

    David Frim, MD
    Recruiting
  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

    George I Jallo, MD
    Recruiting
  • Boston Children'S Hospital

    Boston, Massachusetts, United States

    Joseph R Madsen, MD
    Recruiting
  • Stony Brook Medical Center

    Stony Brook, New York, United States

    David Chesler, MD
    Recruiting
  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

    Jeffrey R Leonard, MDJulie C Leonard, MD MPH
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Joseph J Zorc, MDPhillip B Storm, MD
    Recruiting
  • Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, United States

    Recruiting
  • Rhode Island Hospital

    Providence, Rhode Island, United States

    Lisa H Merck, MD MPHPetra M Klinge, MD PhD
    Recruiting
  • University of Texas-Houston/children'S Memorial Hermann Hospital

    Houston, Texas, United States

    David Sandberg, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 May 2013
Primary completion
30 Jun 2015
Completion
30 Sept 2015
Last update posted
23 Jun 2015
Registered enrollment
400
Registry id
NCT01881711

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.