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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NeuroDx Development
Sponsor:
Collaborators:
Sinai Hospital of Baltimore
Information provided by (Responsible Party):
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT01323764
First received: March 21, 2011
Last updated: September 23, 2014
Last verified: September 2014

March 21, 2011
September 23, 2014
June 2011
March 2015   (final data collection date for primary outcome measure)
Sensitivity and specificity of ShuntCheck vs SPS [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01323764 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
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

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.

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

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Hydrocephalus
Device: ShuntCheck test
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
Other Name: ShuntCheck
Active Comparator: Radionuclide SPS
Radionuclide Shunt Patency Study
Intervention: Device: ShuntCheck test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact: Michael A Williams, MD (410) 601-1900 michwill@lifebridgehealth.org
United States
 
NCT01323764
NDxDev-SCMP-2012, R43NS067770-01A1
No
NeuroDx Development
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
NeuroDx Development
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP