NCT01881711

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: NeuroDx Development · Industry
• Sex: All
• Age: 35 Months – 29 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suspected CSF Shunt Obstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2013-06-20
• Last updated: 2015-06-23

Locations

11 sites across 1 country: United States