MedPath

Data Collection Using Healthtech (Binah.ai) Applicatio

Not Applicable
Registration Number
CTRI/2023/06/053570
Lead Sponsor
Binah.ai Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Subject must have the ability to understand and provide written informed consent.2. Male or female subject more than or equal to 18 and less than or equal to 65 years of age;3. Subject must be willing and able to comply with study procedures.4.In addition to the above criteria, the target population should include adult subjects with at least one of the following: •Diabetes or pre-diabetes HbA1C 5.7-13% (both inclusive) •Hypertension with systolic measurements above 130 mmHg •Total cholesterol above 200 mg/dl and/or LDL above 130 mg/dl •Atrial fibrillation•Smokers approximately 20-30% of all subjects

Exclusion Criteria

1. Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) 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.

2. Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.

3. Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs.

4. Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.

5. Subject unfit to participate in the study to the judgment of the investigator.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Oxygen saturation, pulse rate, respiratory rate, & blood pressure (systolic & diastolic) data collection using the Binah.ai application & reference devices <br/ ><br>2.Estimation through blood sample <br/ ><br>(Complete Blood Count ,HbA1C, Lipid Profile ,Cotinine, Glucose, Albumin, Globulin, Neutrophils, Lymphocytes, Creatinine, Urea, Sodium, Kalium, Calcium, hsCRP & Magnesium.)Timepoint: Single day study
Secondary Outcome Measures
NameTimeMethod
ILTimepoint: NI
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