Clinical trial NCT01881711: ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Suspected CSF Shunt Obstruction
Keywords: hydrocephalus
CSF shunt
shunt malfunction
shunt obstruction
ShuntCheck
ShuntCheck-Micro-Pumper
Lead sponsor: NeuroDx Development
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-06-20
Enrollment: 400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy compared with clinical outcomes
timeFrame: 7 days
measure: Positive Predictive Value (PPV)
timeFrame: 7 days
measure: Negative Predictive Value (NPV)
timeFrame: 7 days
measure: Safety
timeFrame: 1 day
Secondary outcomes:
measure: Rule Out for Low Risk Cases
timeFrame: 7 days
measure: Increased PPV and NPV for Uncertain Cases
timeFrame: 7 days
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: A I dePont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Comer Children's Hospital
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook Medical Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: University of Texas-Houston/Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: Boston Children's Hospital
name: Joseph R Madsen, MD
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: George I Jallo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago Comer Children's Hospital
name: David A Frim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas-Houston/Children's Memorial Hermann Hospital
name: David Sandberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Phillip B Storm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Joseph J Zorc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Robert W Hickey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Mandeep Tamber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Lisa H Merck, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Isalnd Hospital
name: Petra M Klinge, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Robert F Keating, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: James Chamberlain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Jeffrey R Leonard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Julie C Leonard, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred I. duPont Hospital for Children
name: Joseph H Piatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred I. duPont Hospital for Children
name: Jonathan E Bennett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook Medical Center
name: David Chesler, MD
role: PRINCIPAL_INVESTIGATOR
References: