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

Normal Pressure Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00793416
• Other study ID #: NDX01-22-2003
• Status: Withdrawn
• Phase: Phase 4
• First received: November 17, 2008
• Last updated: October 28, 2013
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: NeuroDx Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Adult Patients > 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.

2. Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction

3. Patients are candidates for shunt patency procedures in the elective extension

Exclusion Criteria:

1. Patients <35 years of age

2. Patients with symptoms attributable to valve malfunction or shunt infection

3. Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.

4. Patients with edema or wound of skin overlying the shunt tissue.

5. Patients not capable or not willing to consent to participate in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Device:
• Shunt flow detection
Shunt flow detection based upon ShuntCheck results compared to radionuclide test results

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
NeuroDx Development	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction		Pre and post shunt revision surgery	No
Secondary	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	Yes