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

NeuroDx Development

Status and phase: Withdrawn; Phase 4

Conditions: Normal Pressure Hydrocephalus

Treatments: Device: Shunt flow detection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00793416

NDX01-22-2003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

ShuntCheck measure

Experimental group

Description:

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

Treatment:

Device: Shunt flow detection