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

Primary Purpose

Hydrocephalus

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

ShuntCheck test

About this trial

This is an interventional diagnostic trial for Hydrocephalus focused on measuring Hydrocephalus, CSF shunts, Normal Pressure Hydrocephalus, NPH, ShuntCheck, Shunt Malfunction, Suspected shunt malfunction in adult hydrocephalus patients

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sinai Hospital of Baltimore, LifeBridge Health

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Radionuclide SPS

Arm Description

Radionuclide Shunt Patency Study

Outcomes

Primary Outcome Measures

Sensitivity and specificity of ShuntCheck vs SPS

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01323764

First Posted

March 21, 2011

Last Updated

October 19, 2015

Sponsor

NeuroDx Development

Collaborators

Sinai Hospital of Baltimore, National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT01323764

Brief Title

ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

Acronym

SCNPH

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroDx Development

Collaborators

Sinai Hospital of Baltimore, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hydrocephalus

Keywords

Hydrocephalus, CSF shunts, Normal Pressure Hydrocephalus, NPH, ShuntCheck, Shunt Malfunction, Suspected shunt malfunction in adult hydrocephalus patients

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radionuclide SPS

Arm Type

Active Comparator

Arm Description

Radionuclide Shunt Patency Study

Intervention Type

Device

Intervention Name(s)

ShuntCheck test

Other Intervention Name(s)

ShuntCheck

Intervention Description

Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing

Primary Outcome Measure Information:

Title

Sensitivity and specificity of ShuntCheck vs SPS

Description

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Williams, MD

Organizational Affiliation

Sinai Hospital of Baltimore, LifeBridge Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sherman C Stein, MD

Organizational Affiliation

NeuroDx Development

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marek Swoboda, PhD

Organizational Affiliation

NeuroDx Development

Official's Role

Study Director

Facility Information:

Facility Name

Sinai Hospital of Baltimore, LifeBridge Health

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.lifebridgehealth.org/

Description

Related Info

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ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

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