Binah.ai Visual Vitals Application - Validation Study
Completed
Conditions studied: Respiratory and Pulse Rate Accuracy Validation
In brief
The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a standard ECG reference (respectively).
Key facts
- Study ID
- NCT05539612
- Run by
- Binah.ai LTD.
- People needed
- 30
- Starts
- 2022-07-18
- Expected to finish
- 2022-08-12
- Last updated by the study team
- 2022-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject must have the ability to understand and provide written informed consent
- Subject must be ≥18 years of age
- Subject must be willing and able to comply with study procedures and duration
You may not qualify if…
- Subjects who refuse or are unable to provide 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 of fingers, toes, hands, ears or forehead/skull or other sensor Region Of Interest (ROI) which would limit the ability to test ROI needed for the study.
- Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular areas utilized.)
- Subjects 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
- Clinimark, LLC — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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