Expired Study
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Milwaukee, Wisconsin 53226


Purpose:

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.


Study summary:

The study hypothesis is that a transcutaneously powered ultrasonic flow sensor for hydrocephalic shunts can be repeatedly and accurately read by medical personnel ranging from nurses to senior neurosurgeons. The test will involve a prototype implantable hydrocephalic shunt flow sensor and readout electronics. The readout electronics use a pickup coil to transcutaneously operate the sensor once the coil is aligned with sensor's inductive coupling coils. During the test, the shunt flow sensor will be hidden under a thick saline gel pad whose thickness approximates the skin thickness of an older pediatric patient. A syringe pump will provide a known flow rate through tubing connected to the sensor, but the study participants will not know the pump flow setting. Three neurosurgeons and six floor nurses will perform this study. Each will use the Transonic flowmeter readout to align the pickup coils of the flowmeter with the hidden sensor to make flow measurements. Each participant will repeat this measurement multiple times over non-consecutive days. The recorded data will quantify measurement accuracy and repeatability between different operators, and will determine whether operator skill influences flow measurement accuracy.


Criteria:

Inclusion Criteria: - neurosurgeon - nurse Exclusion Criteria: - none


Study is Available At:


Original ID:

TSI-G-HYDRO-1C-H


NCT ID:

NCT00651950


Secondary ID:

2R44NS049680-02


Study Acronym:


Brief Title:

Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability


Official Title:

A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Transonic Systems Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Withdrawn due to lack of enrollment.


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: C


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Cornelis J Drost, BS, MS
Principal Investigator
Transonic Systems Inc.

Study Dates

Start Date:March 2009
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 4, 2012
First Received Date:March 31, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Flow measurement accuracy vs. the number of times the measurement is conducted.
Time Frame:Daily, weekly
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Standard deviation of error between operator-measured flow measurements and actual flow measurements.
Time Frame:Daily and weekly
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Operator Dependence

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Transonic Systems Inc.
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Neurological Disorders and Stroke (NINDS)

Samples and Retentions

Study Population: Three neurosurgeons and six nurses
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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