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Human Factoring Validation of Pulsenmore ES Device

NCT06567067 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2024-08-22

No results posted yet for this study

Summary

The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and healthcare professionals (HCP)) to evaluate whether the device/user interface can be used by the intended users without any serious issues or errors under that intended use and actual use conditions. The intended users will be qualitatively assessed via observation and cognitive debrief and usability testing methodology. Participants will be remotely observed during the video-guided fetal scanning actual process and participants and HCPs will be remotely observed during the clinician-guided fetal scanning actual process.

Conditions

  • Pregnancy Related

Interventions

DEVICE

Pulsenmore ES home ultrasound

Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched

Sponsors & Collaborators

  • PulseNmore

    lead INDUSTRY

Principal Investigators

  • Susan Dallabrida · SPRIM PRO

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2023-12-21
Completion
2023-12-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567067 on ClinicalTrials.gov