ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

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Brief Title

ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

Official Title

A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction

Brief Summary

      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.
    

Detailed Description

      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
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Sensitivity and specificity of ShuntCheck vs SPS


Condition

Hydrocephalus

Intervention

ShuntCheck test

Study Arms / Comparison Groups

 Radionuclide SPS
Description:  Radionuclide Shunt Patency Study

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

June 2011

Completion Date

July 2015

Primary Completion Date

June 2015

Eligibility Criteria

        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.
      

Gender

All

Ages

35 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael A Williams, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01323764

Organization ID

NDxDev-SCMP-2012

Secondary IDs

R43NS067770-01A1

Responsible Party

Sponsor

Study Sponsor

NeuroDx Development

Collaborators

 Sinai Hospital of Baltimore

Study Sponsor

Michael A Williams, MD, Principal Investigator, Sinai Hospital of Baltimore, LifeBridge Health


Verification Date

October 2015