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Sponsors and Collaborators: |
Transonic Systems Inc. Children's Hospital and Health System Foundation, Wisconsin Medical College of Wisconsin |
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Information provided by: | Transonic Systems Inc. |
ClinicalTrials.gov Identifier: | NCT00652197 |
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.
The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.
After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.
This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.
Condition |
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Hydrocephalus |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study |
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 |
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1
Pediatric hydrocephalus patients that are in recovery from shunt explanation.
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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.
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Transonic Systems Inc. ( Cornelis J. Drost, President & CEO, Transonic Systems Inc. ) |
Study ID Numbers: | TSI-G-HYDRO-1A-H, 2 R44 NS049680-02 |
Study First Received: | March 31, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00652197 |
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 |
Nervous System Diseases |