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NCT06567067 · ClinicalTrials.gov registry record
Human Factoring Validation of Pulsenmore ES Device
A clinical trial, sponsored by PulseNmore.
- Completed
- Registry status
- 57
- Enrollment target
NCT06567067: Completed study, sponsored by PulseNmore.
NCT06567067 is a clinical trial that has completed, run by PulseNmore. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06567067 has completed, sponsored by PulseNmore.
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
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.
Primary Outcome
Any safety issue, either serious that could cause serious injury or death to the user, or non serious
Interventions
- DEVICE Pulsenmore ES home ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2023-12-21 |
What the finished NCT06567067 record still lists
NCT06567067 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Pulsenmore ES home ultrasound is the first listed.
NCT06567067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06567067 about?
NCT06567067 is a clinical study titled "Human Factoring Validation of Pulsenmore ES Device". 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 in...
What is the current status of trial NCT06567067?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2023-02-09. Estimated completion is 2023-12-21.
What interventions are being tested in trial NCT06567067?
The interventions under investigation include: Pulsenmore ES home ultrasound (DEVICE).
Who is sponsoring clinical trial NCT06567067?
This trial is sponsored by PulseNmore, which has 3 total clinical trials registered on ClinicalTrials.gov.
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