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