ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by NeuroDx Development
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT01881711
First received: June 13, 2013
Last updated: February 17, 2014
Last verified: February 2014

June 13, 2013
February 17, 2014
May 2013
June 2014   (final data collection date for primary outcome measure)
  • Diagnostic accuracy compared with clinical outcomes [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
  • Positive Predictive Value (PPV) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
  • Negative Predictive Value (NPV) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
  • Safety [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    To determine if any adverse events were caused by the device or procedure while using the study device.
Same as current
Complete list of historical versions of study NCT01881711 on ClinicalTrials.gov Archive Site
  • Rule Out for Low Risk Cases [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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"
  • Increased PPV and NPV for Uncertain Cases [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation.
Same as current
Not Provided
Not Provided
 
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Suspected CSF Shunt Obstruction
  • 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:
    • CT Scan
    • MRI
  • 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.
    Interventions:
    • Device: ShuntCheck-Micro-Pumper (SCMP)
    • Device: Imaging
  • 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.
    Intervention: Device: Imaging
  • 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
    Intervention: Device: ShuntCheck-Micro-Pumper (SCMP)
  • 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
    Intervention: Device: Imaging
  • 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
    Interventions:
    • Device: ShuntCheck-Micro-Pumper (SCMP)
    • Device: Imaging
  • 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
    Intervention: Device: Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
September 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
35 Months to 20 Years
No
Contact: Joseph R Madsen, MD 617) 355-6005 Joseph.Madsen@childrens.harvard.edu
Contact: Eun-Hyoung Park 617.355.6558 Eun-Hyoung.Park@childrens.harvard.edu
United States
 
NCT01881711
NDxDev-SCMP-2013, R44NS067772
Yes
NeuroDx Development
NeuroDx Development
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: Joseph R Madsen, MD Children's Hospital Boston
Principal Investigator: George I Jallo, MD Johns Hopkins University
Principal Investigator: Frederick A Boop, MD LeBonheur Children's Hospital
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: Mark Luciano, MD The Cleveland Clinic
Principal Investigator: Phillip B Storm, MD Children's Hospital of Philadelphia
Principal Investigator: Joseph J Zorc, MD Children's Hospital of Philadelphia
NeuroDx Development
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP