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

Sponsor

NeuroDx Development (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00793416

Collaborator

Johns Hopkins University (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Normal Pressure Hydrocephalus	Device: Shunt flow detection	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ShuntCheck measure All patients will have ShuntCheck measurements along with radionuclide shunt patency testing.	Device: Shunt flow detection Shunt flow detection based upon ShuntCheck results compared to radionuclide test results

Arm

Intervention/Treatment

Experimental: ShuntCheck measure

All patients will have ShuntCheck measurements along with radionuclide shunt patency testing.

Device: Shunt flow detection

Shunt flow detection based upon ShuntCheck results compared to radionuclide test results

Outcome Measures

Primary Outcome Measures

Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction [Pre and post shunt revision surgery]

Secondary Outcome Measures

To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study [Pre and post shunt revision surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult Patients > 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.
Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction
Patients are candidates for shunt patency procedures in the elective extension

Exclusion Criteria:

Patients <35 years of age
Patients with symptoms attributable to valve malfunction or shunt infection
Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.
Patients with edema or wound of skin overlying the shunt tissue.
Patients not capable or not willing to consent to participate in the study