Trials / Withdrawn
WithdrawnNCT00652249
Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Transonic Systems Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve. The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag. By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.
Conditions
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-04-03
- Last updated
- 2012-06-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00652249. Inclusion in this directory is not an endorsement.