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

Tracking Information
First Submitted Date ICMJE	March 21, 2011
First Posted Date ICMJE	March 28, 2011
Last Update Posted Date	October 20, 2015
Study Start Date ICMJE	June 2011
Actual Primary Completion Date	June 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 24, 2011)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01323764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
Official Title ICMJE	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 Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Diagnostic
Condition ICMJE	Hydrocephalus
Intervention ICMJE	Device: ShuntCheck test; Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing; Other Name: ShuntCheck
Study Arms	Active Comparator: Radionuclide SPS; Radionuclide Shunt Patency Study; Intervention: Device: ShuntCheck test
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: March 24, 2011)	20
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2015
Actual Primary Completion Date	June 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	35 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01323764
Other Study ID Numbers ICMJE	NDxDev-SCMP-2012; R43NS067770-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	NeuroDx Development
Study Sponsor ICMJE	NeuroDx Development
Collaborators ICMJE	Sinai Hospital of Baltimore; National Institute of Neurological Disorders and Stroke (NINDS)
Investigators ICMJE	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
PRS Account	NeuroDx Development
Verification Date	October 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP