Human Factoring Validation of Pulsenmore ES Device
- Conditions
- Pregnancy Related
- Interventions
- Device: Pulsenmore ES home ultrasound
- Registration Number
- NCT06567067
- Lead Sponsor
- PulseNmore
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Clinician guided Pulsenmore ES home ultrasound Participants will perform a scan using Pulsenmore ES device either in the clinician guided mode, guided by a health care professional via a telehealth visit. Participants and healthcare professionals will be remotely observed during the scan and interviewed by a human factoring researcher right after Video guided Pulsenmore ES home ultrasound Participants will perform a scan using Pulsenmore ES device in the video mode independently following video tutorial. Participants will be remotely observed during the scan and interviewed by a human factoring researcher right after
- Primary Outcome Measures
Name Time Method Safety issues while using Pulsenmore ES device 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 One day Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Center for Fetal Medicine and Women Ultrasound
🇺🇸Los Angeles, California, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States