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Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application | Clinical Trials | Clareo Health

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Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

NCT06508047•Mindset Medical

Summary

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).

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (1)

Element Materials Techonology

Louisville, Colorado, United States

Key Dates

Start Date

July 16, 2024

Primary Completion Date

August 22, 2024

Completion Date

August 22, 2024

Last Updated

March 18, 2026

Enrollment

ACTUAL participants

Conditions

Vital Sign Evaluation

Interventions

Informed Vital Core App

DEVICE