Status:

COMPLETED

Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

Lead Sponsor:

Mindset Medical

Conditions:

Vital Sign Evaluation

Eligibility:

All Genders

22+ years

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 16 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 22 2024

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT06508047

Start Date

July 16 2024

End Date

August 22 2024

Last Update

August 30 2024

Active Locations (1)

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Element Materials Techonology

Louisville, Colorado, United States, 80027