- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323764
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)
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 Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore, LifeBridge Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult men or women > 35 years of age;
- 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;
- Possess a shunt placed for AH;
- A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
- Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study
Exclusion Criteria:
- 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;
- ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
- Presence of an interfering open wound or edema over any portion of the VP shunt;
- Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Radionuclide SPS
Radionuclide Shunt Patency Study
|
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NDxDev-SCMP-2012
- R43NS067770-01A1 (U.S. NIH Grant/Contract)
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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