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A prospective, observational, single-arm, post-marketing clinical follow-up study

A Prospective, open-label Post-marketing clinical Follow-up study aims to assess the safety, performance, and user acceptance of the 72 Hours TraxIt® Cholesteric Liquid Crystal (CLC) Skin Patch Thermometer in a real-world clinical setting - NA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061061
Enrollment
400
Registered
2024-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: A99- Unspecified viral hemorrhagic fever

Interventions

Control Intervention1: omron thermometer: OMRON digital thermometer Model MC-246

Sponsors

Medical Indicators Inc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects will be recruited from both in-patient and out-patient settings of mixed population, adults, pediatric and elderly individuals. i. Adults aged 18 to 65 years ii. Pediatric patients Infants – 6 month to 1 aged Toddlers- 1 to 3 years Children- 3 years to 12 years iii. Adolescents- 12 years to 18 years iv. Elderly individual aged 65 years and above 2. Able to provide inform consent form and for pediatric patients from legal guardian. 3. Inpatients admitted to the hospital for various medical conditions requiring continuous temperature monitoring. 4. Outpatient with chronic conditions or specific health conditions that necessitate continuous temperature monitoring

Exclusion criteria

Exclusion criteria: 1. Children with skin condition or wounds in the patch application area. 2. Children with cognitive impairments affecting their ability to wear patch or follow instruction. 3. Individual with known allergies to adhesives or skin sensitivities in the patch application area.

Design outcomes

Primary

MeasureTime frame
Accuracy of temperature measurement’s, safety profile, usability and patient acceptance, adherence to continuous monitoring, detection of fever or abnormal temperature and device durability and stabilityTimepoint: 24 hour, 48 hour & 72 hour

Secondary

MeasureTime frame
Tolerability, Device longevity, user feedback on design, impact on hospital resource utilization, continuous monitoring compliance.Timepoint: 24 hour, 48 hour & 72 hour

Countries

India

Contacts

Public ContactDr Anil Kumar Goel

AIIMS Raipur

akgoel@aiimsraipur.edu.in9810144784

Outcome results

None listed

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