ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

NeuroDx Development

Status and phase: Unknown; Phase 4

Conditions: Suspected CSF Shunt Obstruction

Treatments: Device: Imaging; Device: ShuntCheck-Micro-Pumper (SCMP)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01881711

NDxDev-SCMP-2013

R44NS067772 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 35 months to 29 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 6 patient groups

SCMP plus Imaging

Experimental group

Description:

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.

Treatment:

Device: Imaging

Device: ShuntCheck-Micro-Pumper (SCMP)

Imaging Alone

Active Comparator group

Description:

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.

Treatment:

Device: Imaging

SCMP Rule Out for Low Risk Cases

Experimental group

Description:

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

Treatment:

Device: ShuntCheck-Micro-Pumper (SCMP)

Imaging Rule for Low Risk Cases

Active Comparator group

Description:

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

Treatment:

Device: Imaging

SCMP plus Imaging in Uncertain Cases

Experimental group

Description:

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

Treatment:

Device: Imaging

Device: ShuntCheck-Micro-Pumper (SCMP)

Imaging alone in Uncertain Cases

Active Comparator group

Description:

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

Treatment:

Device: Imaging