NCT00793416

ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients

Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NeuroDx Development · Industry
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.

Detailed description

This study aims to correlate findings of ShuntCheck and MRI with the Radionuclide patency study. Patients will be enrolled if they have Hydrocephalus or IIH, present with symptoms of shunt obstruction and will need to undergo shunt patency test and an MRI along with standard of care radionuclide study. The ShuntCheck study will be conducted in a clinic, doctor's office or in an emergency room by the treating physician or by trained health care professionals. Also, patients who are found with shunt obstruction as diagnosed by Radionuclide study will undergo shunt revision and the findings of the study will be correlated with operative findings. Post Shunt replacement patients who also receive adjustable valve will be evaluated with shunt Check, before and after adjustment of valves to detect changes in flow as detected by shunt check. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients. Approximately 20 subjects will be enrolled in a single site in this proof of concept, physician sponsored study. An approved, commercial device will be available to the site prior to start of the study.

Conditions

• Normal Pressure Hydrocephalus

Interventions

Type	Name	Description
DEVICE	Shunt flow detection	Shunt flow detection based upon ShuntCheck results compared to radionuclide test results

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-11-19
• Last updated: 2013-10-29

Locations

1 site across 1 country: United States