Trial record 1 of 93 for: shunt patency

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

This study is currently recruiting participants.

Verified June 2013 by NeuroDx Development

Sponsor:

Collaborators:

Sinai Hospital of Baltimore

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

NeuroDx Development

ClinicalTrials.gov Identifier:

NCT01323764

First received: March 21, 2011

Last updated: June 13, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2011

Last Updated Date

June 13, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

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

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

Not Provided

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2014

Estimated Primary Completion Date

March 2014 (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.

Gender

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michael A Williams, MD

(410) 601-1900

michwill@lifebridgehealth.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01323764

Other Study ID Numbers ^ICMJE

NDxDev-SCMP-2012, R43NS067770-01A1

Has Data Monitoring Committee

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

Information Provided By

NeuroDx Development

Verification Date

June 2013

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

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