Sponsor:
NeuroDx Development
Code:
NCT01881711
Conditions
Suspected CSF Shunt Obstruction
Eligibility Criteria
Sex: All
Age: 2 - 29
Healthy Volunteers: Not accepted
Interventions
ShuntCheck-Micro-Pumper (SCMP)
Imaging
Brief summary:
Conditions
Suspected CSF Shunt Obstruction
Study ID
NCT01881711
Start date
May, 2013
Status verified date
Jun, 2015
Completion date
Sep, 2015
Anticipated
Primary completion date
Jun, 2015
Anticipated
Eligibility Criteria
Sex: All
Age: 2 - 29
Healthy Volunteers: Not accepted
Enrollment
400 participants
Anticipated
Allocation
Non randomized
Intervention Model
Parallel Assignment
Primary purpose
Diagnostic
Arms
experimental: SCMP plus Imaging
active comparator: Imaging Alone
experimental: SCMP Rule Out for Low Risk Cases
active comparator: Imaging Rule for Low Risk Cases
experimental: SCMP plus Imaging in Uncertain Cases
active comparator: Imaging alone in Uncertain Cases
Interventions
ShuntCheck-Micro-Pumper (SCMP)
Imaging
Primary outcome measure
Central contacts
Locations
A I dePont Hospital for Children
Recruiting
Wilmington, Delaware, United States, 19803
Contacts
Principal Investigator:
Joseph H Piatt, MD
Children's National Medical Center
Recruiting
Washington, District of Columbia, United States, 20010
Contacts
Principal Investigator:
Robert F Keating, MD
University of Chicago Comer Children's Hospital
Recruiting
Chicago, Illinois, United States, 60637
Contacts
Principal Investigator:
David Frim, MD
Johns Hopkins Hospital
Recruiting
Baltimore, Maryland, United States, 21287
Contacts
Principal Investigator:
George I Jallo, MD
Boston Children's Hospital
Recruiting
Boston, Massachusetts, United States, 02115
Contacts
Principal Investigator:
Joseph R Madsen, MD
Stony Brook Medical Center
Recruiting
Stony Brook, New York, United States, 11794
Contacts
Principal Investigator:
David Chesler, MD
Nationwide Children's Hospital
Recruiting
Columbus, Ohio, United States, 43205
Contacts
Principal Investigator:
Jeffrey R Leonard, MD
Children's Hospital of Philadelphia
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contacts
Principal Investigator:
Phillip B Storm, MD
Children's Hospital of Pittsburgh
Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contacts
Mandeep Tamber, MD
Mandeep.Tamber@chp.eduRhode Island Hospital
Recruiting
Providence, Rhode Island, United States, 02903
Contacts
Principal Investigator:
Lisa H Merck, MD MPH
University of Texas-Houston/Children's Memorial Hermann Hospital
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
David Sandberg, MD
Sponsor
NeuroDx Development
Last update posted
Jun 23, 2015
Last verified
Jun, 2015
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NeuroDx Development on 2015-06-23.