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Device

AN24 in addition to new device (Novii) for Fetal Anoxia

N/A
Waitlist Available
Led By Meg Hill, MBBS
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Term Laboring Patients
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the patient's labor
Awards & highlights

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.

Eligible Conditions
  • Fetal Anoxia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the patient's labor
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the patient's labor for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of the Novii when compared to the AN24

Trial Design

1Treatment groups
Experimental Treatment
Group I: AN24 in addition to new device (Novii)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Novii
2013
N/A
~80
AN24
2013
N/A
~80

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,173 Total Patients Enrolled
Meg Hill, MBBSPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
200 Total Patients Enrolled
~6 spots leftby Sep 2025
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