ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt patency testing (SPS) is required.

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Detailed Description

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The primary objective is to demonstrate that the accuracy of SC and SC+MP for determining whether a VP shunt is patent or obstructed is statistically no different than the accuracy of the accepted standard test, radionuclide shunt patency study, when performed simultaneously.

A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes.

A secondary objective is to compare ShuntCheck flow rate results to simultaneous radionuclide clearance as measured by T1/2. A secondary objective is to demonstrate that ShuntCheck flow rate results are statistically equivalent to simultaneous radionuclide clearance measured by T1/2

Conditions

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Hydrocephalus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Radionuclide SPS

Radionuclide Shunt Patency Study

Group Type ACTIVE_COMPARATOR

ShuntCheck test

Intervention Type DEVICE

Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing

Interventions

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ShuntCheck test

Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing

Intervention Type DEVICE

Other Intervention Names

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ShuntCheck

Eligibility Criteria

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Inclusion Criteria

1. Adult men or women \> 35 years of age;
2. Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
3. Possess a shunt placed for AH;
4. A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
5. Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study

Exclusion Criteria

1. Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
2. ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
3. Presence of an interfering open wound or edema over any portion of the VP shunt;
4. Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No