Trials / Completed
CompletedNCT01889316
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Novii | The Novii is a modified device with similar technology to the AN24 device already being used in the USA. |
| DEVICE | AN24 |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2013-11-01
- Completion
- 2014-01-01
- First posted
- 2013-06-28
- Last updated
- 2014-02-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01889316. Inclusion in this directory is not an endorsement.