A prospective, observational, single-arm, post-marketing clinical follow-up study
- Conditions
- Health Condition 1: A99- Unspecified viral hemorrhagic fever
- Registration Number
- CTRI/2024/01/061061
- Lead Sponsor
- Medical Indicators Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Tolerability, Device longevity, user feedback on design, impact on hospital resource utilization, continuous monitoring compliance.Timepoint: 24 hour, 48 hour & 72 hour