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ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

NCT01323764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-10-20

No results posted yet for this study

Summary

The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt patency testing (SPS) is required.

Conditions

  • Hydrocephalus

Interventions

DEVICE

ShuntCheck test

Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing

Sponsors & Collaborators

  • Sinai Hospital of Baltimore

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • NeuroDx Development

    lead INDUSTRY

Principal Investigators

  • Michael A Williams, MD · Sinai Hospital of Baltimore, LifeBridge Health

  • Sherman C Stein, MD · NeuroDx Development

  • Marek Swoboda, PhD · NeuroDx Development

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-06-30
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323764 on ClinicalTrials.gov