ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

PHASE4UnknownINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

September 30, 2015

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

Trial Locations (11)

11794

RECRUITING

Stony Brook Medical Center, Stony Brook

15224

RECRUITING

Children's Hospital of Pittsburgh, Pittsburgh

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19803

RECRUITING

A I dePont Hospital for Children, Wilmington

20010

RECRUITING

Children's National Medical Center, Washington D.C.

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

43205

RECRUITING

Nationwide Children's Hospital, Columbus

60637

RECRUITING

University of Chicago Comer Children's Hospital, Chicago

77030

RECRUITING

University of Texas-Houston/Children's Memorial Hermann Hospital, Houston

02115

RECRUITING

Boston Children's Hospital, Boston

02903

RECRUITING

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

NeuroDx Development

INDUSTRY

NCT01881711 - ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study | Biotech Hunter | Biotech Hunter