NCT01889316|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Monica Healthcare
interventional
75
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
January 2014
Actual (reported)This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii (a newer device also created by Monica Healthcare) using the same technology with different monitor placement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 1, 2013
Actual (reported)June 28, 2013
Actual (reported)November 2013
Actual (reported)January 2014
Actual (reported)Efficacy of the Novii when compared to the AN24
Both the AN24 device and the Novii device will be placed on the patient's abdomen at the same time. After the patient has delivered their infant, the data from the Novii will be downloaded and checked against that from the AN24 to assess for accuracy of fetal monitoring.
duration of the patient's labor
FDA-cleared device (The AN24 device) used in conjunction with the new device (Novii). Both devices will be placed on the patient's abdomen. Hence the patient acts as their own control.
The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Medical Center
Tucson, Arizona, 85724, United States
Meg Hill, MBBS
University of Arizona
75 participants (actual enrollment reported by the registry).
First Submitted
May 1, 2013
First Posted
June 28, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
February 26, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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