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NCT06395350 · ClinicalTrials.gov registry record · NA
Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
A NA study, sponsored by Spire.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT06395350: Completed NA study, sponsored by Spire.
NCT06395350 is a NA study that has completed, run by Spire. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06395350, a NA study, has completed, sponsored by Spire.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the people who are representative of the intended users under expected use conditions. This summative testing is the culmination of several preliminary analyses including a formative usability evaluation via Cognitive Expert Review Panel and is intended to assess the effectiveness of control measures put in place to reduce/eliminate use-related hazards or potential use errors.
Primary Outcome
Observational techniques will be used to assess the participant's ability to easily use various features on the device and discover whether user errors occur.
Interventions
- DEVICE Spire Health Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2019-09-20 |
| Phase | NA |
What the finished NCT06395350 record still lists
NCT06395350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Spire Health Monitor is the first listed.
NCT06395350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06395350 about?
NCT06395350 is a clinical study titled "Spire Health Remote Patient Monitor Human Factors Summative Study Protocol". This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the people who are representative of the intended users under expected use c...
What is the current status of trial NCT06395350?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2019-09-04. Estimated completion is 2019-09-20.
What interventions are being tested in trial NCT06395350?
The interventions under investigation include: Spire Health Monitor (DEVICE).
Who is sponsoring clinical trial NCT06395350?
This trial is sponsored by Spire, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06395350's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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