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Clinical Trials/NCT06567067
NCT06567067
Completed
Not Applicable

Human Factoring Validation Testing of the Pulsenmore ES Home Ultrasound Monitoring Device for Conducting Fetal Scans During Pregnancy

PulseNmore2 sites in 1 country57 target enrollmentFebruary 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
PulseNmore
Enrollment
57
Locations
2
Primary Endpoint
Safety issues while using Pulsenmore ES device
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 9, 2023
End Date
December 21, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
PulseNmore
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Safety issues while using Pulsenmore ES device

Time Frame: One day

Any safety issue, either serious that could cause serious injury or death to the user, or non serious

User error while using Pulsenmore ES device

Time Frame: One day

Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment

Study Sites (2)

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