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ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)

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ClinicalTrials.gov Identifier: NCT01323764
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hydrocephalus Device: ShuntCheck test Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
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
Study Start Date : June 2011
Primary Completion Date : June 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Radionuclide SPS
Radionuclide Shunt Patency Study
Device: ShuntCheck test
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
Other Name: ShuntCheck

Outcome Measures

Primary Outcome Measures :
  1. Sensitivity and specificity of ShuntCheck vs SPS [ Time Frame: Day 1 ]

    The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test.

    The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction.

Eligibility Criteria

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323764

United States, Maryland
Sinai Hospital of Baltimore, LifeBridge Health
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
NeuroDx Development
Sinai Hospital of Baltimore
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Michael A Williams, MD Sinai Hospital of Baltimore, LifeBridge Health
Study Chair: Sherman C Stein, MD NeuroDx Development
Study Director: Marek Swoboda, PhD NeuroDx Development
More Information

Additional Information:
Responsible Party: NeuroDx Development
ClinicalTrials.gov Identifier: NCT01323764     History of Changes
Other Study ID Numbers: NDxDev-SCMP-2012
R43NS067770-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by NeuroDx Development:
CSF shunts
Normal Pressure Hydrocephalus
Shunt Malfunction
Suspected shunt malfunction in adult hydrocephalus patients

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases