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NCT01889316 · ClinicalTrials.gov registry record · NA
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
A NA study, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT01889316: Completed NA study, sponsored by University of Arizona.
NCT01889316 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01889316, a NA study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Novii
- DEVICE AN24
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01889316 record still lists
NCT01889316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Novii is the first listed.
NCT01889316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01889316 about?
NCT01889316 is a clinical study titled "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.
What is the current status of trial NCT01889316?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2013-04. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01889316?
The interventions under investigation include: Novii (DEVICE), AN24 (DEVICE).
Who is sponsoring clinical trial NCT01889316?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01889316's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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