Physician Preference Study of ShuntCheck - Madsen

June 22, 2015 updated by: NeuroDx Development

Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts

ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.

Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Children's Hospital Boston
        • Principal Investigator:
          • Joseph R Madsen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
  2. Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
  3. Subjects must be physically stable as determined by the physician.

Exclusion Criteria:

  1. Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
  2. Subjects unable to lie supine with head elevated 30 degrees or less
  3. Subjects who have had shunt surgery within two weeks.
  4. Inability or unwillingness of subject to endure the test.
  5. Other judgments of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic
Device: ShuntCheck
Thermal dilution test for CSF flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
Time Frame: Tested in single visit
Tested in single visit

Secondary Outcome Measures

Outcome Measure
Time Frame
ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction
Time Frame: Single visit
Single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroDx Development

Collaborators

Boston Children's Hospital

Investigators

  • Principal Investigator: Joseph R Madsen, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDX 07-07-0277
  • 07-07-0277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe