ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
NCT ID: NCT01881711
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2013-05-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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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.
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.
Imaging
Imaging of ventricle size
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.
Imaging
Imaging of ventricle size
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
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.
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
Imaging
Imaging of ventricle size
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
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.
Imaging
Imaging of ventricle size
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
Imaging
Imaging of ventricle size
Interventions
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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.
Imaging
Imaging of ventricle size
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
35 Months
29 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
NeuroDx Development
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph R Madsen, MD
Role: STUDY_CHAIR
Boston Children's Hospital
George I Jallo, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
David A Frim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comer Children's Hospital
David Sandberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas-Houston/Children's Memorial Hermann Hospital
Phillip B Storm, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Joseph J Zorc, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Robert W Hickey, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Mandeep Tamber, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Lisa H Merck, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Petra M Klinge, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rhode Isalnd Hospital
Robert F Keating, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
James Chamberlain, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Jeffrey R Leonard, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Julie C Leonard, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Joseph H Piatt, MD
Role: PRINCIPAL_INVESTIGATOR
Alfred I. duPont Hospital for Children
Jonathan E Bennett, MD
Role: PRINCIPAL_INVESTIGATOR
Alfred I. duPont Hospital for Children
David Chesler, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook Medical Center
Locations
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A I dePont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Stony Brook Medical Center
Stony Brook, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas-Houston/Children's Memorial Hermann Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NDxDev-SCMP-2013
Identifier Type: -
Identifier Source: org_study_id
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