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Testing of the BOLT device to evaluate its performance which measures Blood Pressure,Body temperature, Oxygen Saturation and Pulse.

Validation of B.O.L.T Body Life Tracker Device reports in measuring Blood Pressure (BP), Body Temperature, Blood Oxygen saturation (SpO2) and Pulse as per applicable ISO Standards.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/12/016558
Enrollment
150
Registered
2018-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R030- Elevated blood-pressure reading, without diagnosis of hypertension Health Condition 2: R509- Fever, unspecified Health Condition 3: R031- Nonspecific low blood-pressure reading Health Condition 4: R068- Other abnormalities of breathing Health Condition 5: R009- Unspecified abnormalities of heartbeat

Interventions

None listed

Sponsors

American Megatrends India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject is willing to give written informed consent for participation in the study. 2. Male or Female, aged 18 years or above. 3. Subjects having one or more following medical history. a) Blood Pressure b) Fever c) Low oxygen saturation level.

Exclusion criteria

Exclusion criteria: 1. Geriatric subjects above 75 years of age. 2. Mentally challenged subjects.

Design outcomes

Primary

MeasureTime frame
For all the below parameters the measurement by test and reference values will be compared 1. Blood Pressure (BP) 2. Body Temperature 3. Blood Oxygen saturation (SpO2) 4. PulseTimepoint: Same Day—

Secondary

MeasureTime frame
Ease of use of test device will be determined as per the list of questionnaires.Timepoint: Same Day;Ease of use of test device will be determined as per the list of questionnaires.Timepoint: Same Day—

Countries

India

Contacts

Public ContactSubham Dutta

American Megatrends India Pvt Ltd

divyak@amiindia.co.in9790917069

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026