Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
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|ClinicalTrials.gov Identifier: NCT01889316|
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : February 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Labor Fetal Anoxia||Device: Novii Device: AN24||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||January 2014|
AN24 in addition to new device (Novii)
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.
- Efficacy of the Novii when compared to the AN24 [ Time Frame: duration of the patient's labor ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889316
|United States, Arizona|
|University Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Meg Hill, MBBS||University of Arizona|