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NCT05721131 · ClinicalTrials.gov registry record
NC Thermometer (Gen 3) ISO 80601-2-56 Validation
A clinical trial of Healthy and Fever, sponsored by Natural Cycles.
- Completed
- Registry status
- 105
- Enrollment target
- 2
- Study locations
NCT05721131: Completed study of Healthy and Fever, sponsored by Natural Cycles.
NCT05721131 is a study of Healthy and Fever that has completed, run by Natural Cycles. The registered enrollment target is 105 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05721131, a study of Healthy and Fever, has completed, sponsored by Natural Cycles.
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.
Primary Outcome
Clinical bias is the mean difference between the output temperatures of the NC° Thermometer (Gen 3) (DUT) and the reference clinical thermometer (RCT) for a specific reference body site (the mouth) when measured from a selected group of subjects. The clinical bias of the DUT defines closeness between the DUT output temperature and that of the RCT.
Conditions Studied
Interventions
- DEVICE NC° Thermometer (Gen 3)
Study Locations (2)
California
- Choice Health Network- Reyes Health Center - Anaheim
New York
- Natural Cycles - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2023-04-27 |
What the finished NCT05721131 record still lists
NCT05721131 is an observational study that tracks outcomes without assigning an intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which NC° Thermometer (Gen 3) is the first listed.
NCT05721131 reports a single indexed study location in California, New York.
Frequently Asked Questions
What is clinical trial NCT05721131 about?
NCT05721131 is a clinical study titled "NC Thermometer (Gen 3) ISO 80601-2-56 Validation". The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.
What is the current status of trial NCT05721131?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2023-01-10. Estimated completion is 2023-04-27.
What conditions does trial NCT05721131 study?
This clinical trial studies the following conditions: Healthy, Fever, Febrile Illness.
What interventions are being tested in trial NCT05721131?
The interventions under investigation include: NC° Thermometer (Gen 3) (DEVICE).
Who is sponsoring clinical trial NCT05721131?
This trial is sponsored by Natural Cycles, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05721131 being conducted?
This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05721131's enrollment target sits among peer trials
105 210th of 1090 higher than 879 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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