ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

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

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• NeuroDx Development

  lead INDUSTRY

Principal Investigators

• Joseph R Madsen, MD · Boston Children's Hospital

• George I Jallo, MD · Johns Hopkins University

• David A Frim, MD · University of Chicago Comer Children's Hospital

• David Sandberg, MD · University of Texas-Houston/Children's Memorial Hermann Hospital

• Phillip B Storm, MD · Children's Hospital of Philadelphia

• Joseph J Zorc, MD · Children's Hospital of Philadelphia

• Robert W Hickey, MD · University of Pittsburgh

• Mandeep Tamber, MD · University of Pittsburgh

• Lisa H Merck, MD MPH · Rhode Island Hospital

• Petra M Klinge, MD PhD · Rhode Isalnd Hospital

• Robert F Keating, MD · Children's National Research Institute

• James Chamberlain, MD · Children's National Research Institute

• Jeffrey R Leonard, MD · Nationwide Children's Hospital

• Julie C Leonard, MD MPH · Nationwide Children's Hospital

• Joseph H Piatt, MD · Alfred I. duPont Hospital for Children

• Jonathan E Bennett, MD · Alfred I. duPont Hospital for Children

• David Chesler, MD · Stony Brook Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Months

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2015-06-30

Completion

2015-09-30

Countries

• United States

Study Locations