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

October 28, 2013 updated by: NeuroDx Development

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

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction
Time Frame: Pre and post shunt revision surgery
Pre and post shunt revision surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study
Time Frame: Pre and post shunt revision surgery
Pre and post shunt revision surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Daniele Rigamonti, MD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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