Study Stopped
Withdrawn due to lack of enrollment.
Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability
A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability
2 other identifiers
observational
N/A
1 country
1
Brief Summary
The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements. The study participants will align the flowmeter probe with a flow sensor hidden under a thick saline pad that simulates skin. A hidden pump will provide a known flow through the flow sensor as the participants make their measurements. Each participant will repeat these measurements over a period of weeks, and the data will tell whether operator skill influences flow measurement accuracy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 5, 2012
June 1, 2012
1.8 years
March 31, 2008
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standard deviation of error between operator-measured flow measurements and actual flow measurements.
Daily and weekly
Secondary Outcomes (1)
Flow measurement accuracy vs. the number of times the measurement is conducted.
Daily, weekly
Study Arms (1)
Operator Dependence
Eligibility Criteria
Three neurosurgeons and six nurses
You may qualify if:
- neurosurgeon
- nurse
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cornelis J Drost, BS, MS
Transonic Systems Inc.
- STUDY DIRECTOR
Bruce A Kaufman, MD
Children's Hospital and Health System Foundation, Wisconsin
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 3, 2008
Study Start
March 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 5, 2012
Record last verified: 2012-06