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NCT04232215 · ClinicalTrials.gov registry record · NA

Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use

A NA study, sponsored by Mayo Clinic.

Completed
Registry status
NA
Development phase
59
Enrollment target

NCT04232215: Completed NA study, sponsored by Mayo Clinic.

NCT04232215 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 59 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04232215, a NA study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
NA
Development phase
59 participants
Enrollment target

Study Summary

Researchers are assessing the ease of use and accuracy of the HeraBEAT™ device, a new device used with a smartphone to monitor fetal heart rate during pregnancy.

Primary Outcome

Measured using the self-reported System Usability Scale (SUS) on 10 items, each on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree). A composite score is calculated with a range of 0-100 where higher values indicated a high usability of device, whereas lower scores indicate less usability of the device.

Interventions

  • DEVICE HeraBEAT™
  • DEVICE Doppler fetal heart rate monitor

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2021-02-03
Est. Completion 2022-08-31
Phase NA
Mayo Clinic

2,844 total trials

What the finished NCT04232215 record still lists

NCT04232215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which HeraBEAT™ is the first listed.

NCT04232215 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04232215 about?

NCT04232215 is a clinical study titled "Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use". Researchers are assessing the ease of use and accuracy of the HeraBEAT™ device, a new device used with a smartphone to monitor fetal heart rate during pregnancy.

What is the current status of trial NCT04232215?

This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2021-02-03. Estimated completion is 2022-08-31.

What interventions are being tested in trial NCT04232215?

The interventions under investigation include: HeraBEAT™ (DEVICE), Doppler fetal heart rate monitor (DEVICE).

Who is sponsoring clinical trial NCT04232215?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04232215's enrollment target sits among peer trials

59 1256th of 2000 higher than 745 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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Source: ClinicalTrials.gov NCT04232215, the US trial registry maintained by the National Library of Medicine. NCT04232215 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.