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

NCT ID: NCT00793416

Last Updated: 2013-10-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-08-31

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.

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

Keywords

Normal Pressure Hydrocephalus; Valve Adjustment; Blocked Shunt in NPH patients; Diagnosis of blockage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ShuntCheck measure

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

Group Type: EXPERIMENTAL

Shunt flow detection

Intervention Type: DEVICE

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

Interventions

Shunt flow detection

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

NeuroDx Development

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniele Rigamonti, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NDX01-22-2003

Identifier Type: -

Identifier Source: org_study_id