Multi-Center Study of ShuntCheck

This study has been withdrawn prior to enrollment.
(Insufficient funding)
Sponsor:
Information provided by:
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT00788385
First received: November 7, 2008
Last updated: November 19, 2009
Last verified: November 2009

November 7, 2008
November 19, 2009
June 2009
June 2010   (final data collection date for primary outcome measure)
Not Provided
The outcome measure is the sensitivity and specificity of ShuntCheck compared to clinical outcome at 7days or surgical outcome. [ Time Frame: 7- day period ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00788385 on ClinicalTrials.gov Archive Site
Not Provided
The number and percent of subjects experiencing adverse which take place within 24 hours of ShuntCheck [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Multi-Center Study of ShuntCheck
Multi-Center Study of ShuntCheck

Multi-Center Study of ShuntCheck

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Blocked Ventricular Shunts
Device: ShuntCheck test
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
350
December 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Exclusion Criteria:

Both
1 Month to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00788385
NDX01-22-2001
No
Fred Fritz, Neuro Diagnostic Devices
NeuroDx Development
Not Provided
Not Provided
NeuroDx Development
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP