NCT01323764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

4 years

First QC Date

March 21, 2011

Last Update Submit

October 19, 2015

Conditions

Hydrocephalus

Keywords

HydrocephalusCSF shuntsNormal Pressure HydrocephalusNPHShuntCheckShunt MalfunctionSuspected shunt malfunction in adult hydrocephalus patients

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Radionuclide SPS

ACTIVE COMPARATOR

Radionuclide Shunt Patency Study

Device: ShuntCheck test

Interventions

ShuntCheck testDEVICE

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

Also known as: ShuntCheck
Radionuclide SPS

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Hospital of Baltimore, LifeBridge Health

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

HydrocephalusHydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 28, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

US(1)