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
  Purpose

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.


Condition Intervention Phase
Suspected CSF Shunt Obstruction
Device: ShuntCheck-Micro-Pumper (SCMP)
Device: Imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NeuroDx Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CT Scan
  • MRI
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:
  • CT Scan
  • MRI
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:
  • CT Scan
  • MRI
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:
  • CT Scan
  • MRI
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:
  • CT Scan
  • MRI

  Eligibility

Ages Eligible for Study:   35 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881711

Contacts
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

Locations
United States, Illinois
University of Chicago Comer Children's Hospital Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: David Frim, MD    773-702-2475    dfrim@peds.bsd.uchicago.edu   
Principal Investigator: David Frim, MD         
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: George I Jallo, MD    410-955-7851    gjallo1@jhmi.edu   
Principal Investigator: George I Jallo, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joseph R Madsen, MD    617-355-6005    Joseph.Madsen@childrens.harvard.edu   
Contact: Laurel Fleming    617.448.3072    laurel.fleming@childrens.harvard.edu   
Principal Investigator: Joseph R Madsen, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Mark Luciano, MD    216-636-5860    Lucianm@ccf.org   
Principal Investigator: Mark Luciano, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Phillip B Storm, MD    215-590-2780    storm@email.chop.edu   
Contact: Joseph J Zorc, MD    (215) 776-4285    zorc@email.chop.edu   
Principal Investigator: Phillip B Storm, MD         
Principal Investigator: Joseph J Zorc, MD         
United States, Tennessee
LeBonheur Children's Hospital Not yet recruiting
Memphis, Tennessee, United States, 38120
Contact: Frederick A Boop, MD    901-259-5321    faboop@aol.com   
Principal Investigator: Frederick A Boop, MD         
United States, Texas
University of Texas-Houston/Children's Memorial Hermann Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: David Sandberg, MD    713-500-7306    David.I.Sandberg@uth.tmc.edu   
Principal Investigator: David Sandberg, MD         
Sponsors and Collaborators
NeuroDx Development
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: NeuroDx Development
ClinicalTrials.gov Identifier: NCT01881711     History of Changes
Other Study ID Numbers: NDxDev-SCMP-2013, R44NS067772
Study First Received: June 13, 2013
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NeuroDx Development:
hydrocephalus
CSF shunt
shunt malfunction
shunt obstruction
ShuntCheck
ShuntCheck-Micro-Pumper

ClinicalTrials.gov processed this record on August 21, 2014