Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Completed
Conditions studied: Vital Sign Evaluation
In brief
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including respiratory rate (RR). The purpose of the study is to conduct accuracy validation when compared to a FDA-cleared/approved vital sign monitoring device (reference device).
Key facts
- Study ID
- NCT06508047
- Run by
- Mindset Medical
- People needed
- 68
- Starts
- 2024-07-16
- Expected to finish
- 2024-08-22
- Last updated by the study team
- 2026-03-18
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate.
- Participant must be ≥22 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participants or legally authorized representative must be able to read or write in English
You may not qualify if…
- Participants who refuse or are unable to sign an informed written consent for study
- Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
- Compromised circulation, injury, or physical malformation the Region of Interest (ROI) which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
- Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
- Other known health condition, should be considered upon disclosure in health assessment form
Where it is running
- Element Materials Techonology — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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