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| Sponsors and Collaborators: |
Transonic Systems Inc. Children's Hospital and Health System Foundation, Wisconsin Medical College of Wisconsin |
|---|---|
| Information provided by: | Transonic Systems Inc. |
| ClinicalTrials.gov Identifier: | NCT00652249 |
Purpose
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.
| Condition |
|---|
|
Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Cohort, Cross-Sectional |
| Official Title: | A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve |
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Pediatric hydrocephalus patients that are in recovery from shunt explanation.
|
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bruce A Kaufman, MD | 414-266-6435 | bkaufman@mcw.edu |
| Contact: Sean M Lew, MD | 414-266-6435 | slew@mcw.edu |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Cornelis J Drost, BS, MS | Transonic Systems Inc. |
| Study Director: | Bruce A Kaufman, MD | Children's Hospital and Health System Foundation, Wisconsin |
More Information
| Responsible Party: | Transonic Systems Inc. ( Cornelis J. Drost, President & CEO, Transonic Systems Inc. ) |
| Study ID Numbers: | TSI-G-HYDRO-1B-H, 2 R44 NS049680-02 |
| Study First Received: | March 31, 2008 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00652249 |
| Health Authority: | United States: Food and Drug Administration |
|
Hydrocephalus shunt dysfunction shunt flow |
|
Pseudotumor cerebri Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases |
Hydrocephalus Brain Diseases Intracranial Hypertension Hypertension |
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Nervous System Diseases |
