ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

June 22, 2015 updated by: NeuroDx Development

An Operator-Blinded Study of the Efficacy of ShuntCheck-Micro-Pumper, a Non-Invasive Diagnostic Procedure, in Detecting Ventricular Shunt Patency or Occlusion and in Predicting Clinical Outcome in Children and Adolescents Presenting to Emergency Departments and Neurosurgery Clinics

Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • A I dePont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Joseph H Piatt, MD
        • Principal Investigator:
          • Jonathan E Bennett, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
        • Principal Investigator:
          • Robert F Keating, MD
        • Principal Investigator:
          • James Chamberlain, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comer Children's Hospital
        • Contact:
        • Principal Investigator:
          • David Frim, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Principal Investigator:
          • George I Jallo, MD
    • Massachusetts
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook Medical Center
        • Contact:
        • Principal Investigator:
          • David Chesler, MD
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey R Leonard, MD
        • Principal Investigator:
          • Julie C Leonard, MD MPH
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Phillip B Storm, MD
        • Principal Investigator:
          • Joseph J Zorc, MD
      • Pittsburgh, Pennsylvania, United States, 15224
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Principal Investigator:
          • Lisa H Merck, MD MPH
        • Principal Investigator:
          • Petra M Klinge, MD PhD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas-Houston/Children's Memorial Hermann Hospital
        • Contact:
        • Principal Investigator:
          • David Sandberg, 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

2 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females, older than 35 months and less than 20 years of age.
  2. Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
  3. Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
  4. Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition
  5. Will be available for follow-up for up to 7 days

Exclusion Criteria:

  1. Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
  2. Presence of multiple shunts or known non-functioning shunts crossing the clavicle.
  3. Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination.
  4. SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
  5. Presence of an interfering open wound or edema over the shunt.
  6. Likelihood, in the judgment of the investigator, of the subject being lost to follow-up as a result of subject unavailability or clinical outcome being unobtainable.
  7. Any other condition that would preclude or bias the results of the study according to the judgment of the investigator.
  8. Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCMP plus Imaging
SCMP plus Imaging will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Device: ShuntCheck-Micro-Pumper (SCMP)
ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.
Device: Imaging
Imaging of ventricle size
Other Names:
  • MRI
  • CT Scan
Active Comparator: Imaging Alone
Imaging alone will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Device: Imaging
Imaging of ventricle size
Other Names:
  • MRI
  • CT Scan
Experimental: SCMP Rule Out for Low Risk Cases
SCMP results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction
Device: ShuntCheck-Micro-Pumper (SCMP)
ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.
Active Comparator: Imaging Rule for Low Risk Cases
Imaging results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction
Device: Imaging
Imaging of ventricle size
Other Names:
  • MRI
  • CT Scan
Experimental: SCMP plus Imaging in Uncertain Cases
SCMP plus imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value
Device: ShuntCheck-Micro-Pumper (SCMP)
ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.
Device: Imaging
Imaging of ventricle size
Other Names:
  • MRI
  • CT Scan
Active Comparator: Imaging alone in Uncertain Cases
Imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value
Device: Imaging
Imaging of ventricle size
Other Names:
  • MRI
  • CT Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy compared with clinical outcomes
Time Frame: 7 days
SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
7 days
Positive Predictive Value (PPV)
Time Frame: 7 days
Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone.
7 days
Negative Predictive Value (NPV)
Time Frame: 7 days
Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone.
7 days
Safety
Time Frame: 1 day
To determine if any adverse events were caused by the device or procedure while using the study device.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rule Out for Low Risk Cases
Time Frame: 7 days
To demonstrate that SCMP plus Physician's judgment is comparable to Physician's judgment plus imaging in ruling out shunt malfunction in patients judged to be "Unlikely to require shunt surgery"
7 days
Increased PPV and NPV for Uncertain Cases
Time Frame: 7 days
To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation.
7 days

Collaborators and Investigators

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

Sponsor

NeuroDx Development

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Study Chair: Joseph R Madsen, MD, Boston Children's Hospital
  • Principal Investigator: George I Jallo, MD, Johns Hopkins University
  • Principal Investigator: David A Frim, MD, University of Chicago Comer Children's Hospital
  • Principal Investigator: David Sandberg, MD, University of Texas-Houston/Children's Memorial Hermann Hospital
  • Principal Investigator: Phillip B Storm, MD, Children's Hospital of Philadelphia
  • Principal Investigator: Joseph J Zorc, MD, Children's Hospital of Philadelphia
  • Principal Investigator: Robert W Hickey, MD, University of Pittsburgh
  • Principal Investigator: Mandeep Tamber, MD, University of Pittsburgh
  • Principal Investigator: Lisa H Merck, MD MPH, Rhode Island Hospital
  • Principal Investigator: Petra M Klinge, MD PhD, Rhode Isalnd Hospital
  • Principal Investigator: Robert F Keating, MD, Children's National Research Institute
  • Principal Investigator: Jeffrey R Leonard, MD, Nationwide Children's Hospital
  • Principal Investigator: Julie C Leonard, MD MPH, Nationwide Children's Hospital
  • Principal Investigator: Jonathan E Bennett, MD, Alfred I. DuPont Hospital for Children
  • Principal Investigator: David Chesler, MD, Stony Brook Medical Center

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

May 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 20, 2013

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

Keywords

Other Study ID Numbers

  • NDxDev-SCMP-2013
  • R44NS067772 (U.S. NIH Grant/Contract)

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.

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