ShuntCheck Versus Radionuclide in Evaluating Shunt Functi... | NCT01323764

Studies
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

NCT01323764

Sponsor

NeuroDx Development

Status

Completed

Last Update Posted

Oct 20, 2015Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Hydrocephalus

Interventions

ShuntCheck test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R43NS067770-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jun 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Mar 21, 2011

First Submission Date that Met QC Criteria

Mar 24, 2011

First Posted Date

Mar 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2015

Last Update Posted Date

Oct 20, 2015Estimated

Name	Class
Sinai Hospital of Baltimore	OTHER
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radionuclide SPS	Active Comparator	Radionuclide Shunt Patency Study	Device: ShuntCheck test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ShuntCheck test	Device	Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing	Radionuclide SPS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael A Williams, MD	Sinai Hospital of Baltimore, LifeBridge Health	Principal Investigator
Sherman C Stein, MD	NeuroDx Development	Study Chair
Marek Swoboda, PhD	NeuroDx Development	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sinai Hospital of Baltimore, LifeBridge Health		Baltimore	Maryland	21215	United States

Condition Browse Module

MeSH Terms

ID	Term
D006849	Hydrocephalus
D006850	Hydrocephalus, Normal Pressure

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided