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Testing of B.O.L.T. device in measuring body temperature in adults.

Validation of B.O.L.T Body Life Tracker Device accuracy in measuring Body Temperature in adults as per ASTM E1965-98(2016).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019773
Enrollment
120
Registered
2019-06-19
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: R509- Fever, unspecified

Interventions

Intervention1: BOLT BT4 Device Model: VA01, VA01-01: B.O.L.T. Body Life Tracker Infrared Thermometer is an adjusted type tympanic infrared thermometer that displays the body temperature range between

Sponsors

AmZetta Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject is willing to give written informed consent for participation in the study. 2. Febrile or Afebrile Male or Female above 18 years of age. (Febrile Subject with associated conditions like nausea, headache, vomiting, cold, cough, etc will also be recruited) 3. Febrile Subjects will be recruited in the temperature range between 35 °C to 42 °C (95 °F to 107.6 °F).

Exclusion criteria

Exclusion criteria: 1. Has complete occlusion of the auditory canal 2. Has Otitis media (middle ear inflammation) 3. Has External Ear Inflammation 4. Has Trauma to the ear 5. Has had Immunization within seven days of the test 6. Use of drugs known to fluctuate body temperature within 3 hours of the test like antipyretics, antibiotics, opioids, antipsychotics and antihistamines)

Design outcomes

Secondary

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

Primary

MeasureTime frame
Quantitative comparison between the paired readings from the test device and standard reference device will be made and considered as per the ASTM 1965-98 (2016).Timepoint: Same Day

Countries

India

Contacts

Public ContactSubham Dutta

AmZetta Technologies Pvt. Ltd.

divyak@amzetta.co.in9790917069

Outcome results

None listed

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