Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method|
- Efficacy of the Novii when compared to the AN24 [ Time Frame: duration of the patient's labor ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2013|
|Study Completion Date:||January 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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.Device: AN24
This study has one arm, in which Both the FDA - Approved AN24 (Fetal Monitoring device marketed by Monica Healthcare) and the new device (Novii, being investigated in this clinical trial) will be placed on the patient's abdomen. After delivery of the patient's infant, the data will be abstracted from the second device. This data will be compared to the data from the first device for accuracy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01889316
|United States, Arizona|
|University Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Meg Hill, MBBS||University of Arizona|