Respiratory and Pulse Rate Accuracy ValidationNCT05539612
Binah.ai Visual Vitals Application - Validation Study
An observational study of Respiratory and Pulse Rate Accuracy Validation, run by Binah.ai LTD. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory and Pulse Rate Accuracy Validation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 12 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From admission to discharge, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start18 Jul 2022
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory and Pulse Rate Accuracy ValidationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binah.ai LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539612
- Sponsor's protocol ID
- 2021-455
- Status last verified
- Oct 2022
- First submitted
- 11 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binah.ai Visual Vitals Application - Validation Study
- ClinicalTrials.gov ID
- NCT05539612
- Acronym / sponsor ID
- 2021-455
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Binah.ai LTD.Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory Rate accuracy validation
Time frame: From admission to discharge, up to 2 hours
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).
Pulse Rate accuracy validation
Time frame: From admission to discharge, up to 2 hours
Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, a standard ECG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory and Pulse Rate Accuracy Validation, run by Binah.ai LTD. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate accuracy validation (time frame: From admission to discharge, up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.