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
Sponsor study identifier
Secondary identifiers
NIH
interventional
400
1 country
11
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 13, 2013
Actual (reported)June 20, 2013
Actual (reported)June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diagnostic accuracy compared with clinical outcomes
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)
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)
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
Rule Out for Low Risk Cases
7 days
Increased PPV and NPV for Uncertain Cases
7 days
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.
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.
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.
A I dePont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Joseph R Madsen, MD
Boston Children's Hospital
George I Jallo, MD
Johns Hopkins University
David A Frim, MD
University of Chicago Comer Children's Hospital
David Sandberg, MD
University of Texas-Houston/Children's Memorial Hermann Hospital
First Submitted
June 13, 2013
First Posted
June 20, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Magnetic Resonance Imaging Evaluation of the Tissular Oxygen Saturation in Brain
Safety
To determine if any adverse events were caused by the device or procedure while using the study device.
1 day
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
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
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
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
Imaging of ventricle size
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University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Stony Brook Medical Center
Stony Brook, New York, 11794, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Texas-Houston/Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Phillip B Storm, MD
Children's Hospital of Philadelphia
Joseph J Zorc, MD
Children's Hospital of Philadelphia
Robert W Hickey, MD
University of Pittsburgh
Mandeep Tamber, MD
University of Pittsburgh
Lisa H Merck, MD MPH
Rhode Island Hospital
Petra M Klinge, MD PhD
Rhode Isalnd Hospital
Robert F Keating, MD
Children's National Research Institute
James Chamberlain, MD
Children's National Research Institute
Jeffrey R Leonard, MD
Nationwide Children's Hospital
Julie C Leonard, MD MPH
Nationwide Children's Hospital
Joseph H Piatt, MD
Alfred I. duPont Hospital for Children
Jonathan E Bennett, MD
Alfred I. duPont Hospital for Children
David Chesler, MD
Stony Brook Medical Center
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2015
Record last verified: 2015-06
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