Trials / Completed
CompletedNCT06567067
Human Factoring Validation of Pulsenmore ES Device
Human Factoring Validation Testing of the Pulsenmore ES Home Ultrasound Monitoring Device for Conducting Fetal Scans During Pregnancy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 57 (actual)
- Sponsor
- PulseNmore · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsenmore ES home ultrasound | Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched |
Timeline
- Start date
- 2023-02-09
- Primary completion
- 2023-12-21
- Completion
- 2023-12-21
- First posted
- 2024-08-22
- Last updated
- 2024-08-22
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06567067. Inclusion in this directory is not an endorsement.