Binah.ai Visual Vitals Application - Validation Study

NCT05539612 | Completed

• 1 other identifier: 2021-455
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Respiratory and Pulse Rate Accuracy Validation

Outcome Measures

Primary Outcomes (2)

• Respiratory Rate accuracy validation

  Respiratory Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).

  From admission to discharge, up to 2 hours

• Pulse Rate accuracy validation

  Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, a standard ECG.

  From admission to discharge, up to 2 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is carefully designed to represent the intended population for the intended use of the Binah.ai Visual Vitals Application. The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute certain proportions of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, Diabetes and Obesity). The goal is to include a range of skin pigmentations, including at least 5 darkly pigmented subjects or 15% of the subject pool, whichever is larger. Subject enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the subject and data demographics needed for the study.

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

Sponsors & Collaborators

• Binah.ai LTD.: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark, LLC

Louisville, Colorado, 80027, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: September 14, 2022
• Study Start: July 18, 2022
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

US (1)