None listed
Conditions
Interventions
Intervention1: Ni: Nil
Control Intervention1: Ni: Nil
Sponsors
Morepen Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age Cohorts - A1 is 0 up to 3 months, A2 is 3 months up to 1 year, B is Older than 1 year and younger than 5 years and C is Older than 5 years. 2. Subjects or legally authorized guardians, for minors must be able to provide written informed consent prior to any study procedures. 3. Parental permission for rectal measurement. Assents will be obtained from children aged 7 years and above in accordance with local regulatory and ethical requirements; local IRB guidance on age thresholds for assent takes precedence. 4. Subjects or guardians must be willing and able to comply with study procedures, including consecutive temperature measurements using both the investigational thermometer (Dr. Morepen DigiClassic MT-110) and the reference thermometer (Omron MC 246), and time-limited environmental procedures for which consent has been provided. 5. Each age cohort will target febrile and afebrile subjects in approximately 1:1 ratio to ensure balanced representation across clinically relevant states. Subjects in the intermediate band (37.5 37.9 C) will be documented separately and retained for descriptive analyses but excluded from primary febrile/afebrile subgroup comparisons. 6. Subjects must have measurement sites accessible and appropriate per IFU and age cohort.
Exclusion criteria
Exclusion criteria: 1. Inability or unwillingness of the subject or guardian to provide informed consent or assent in accordance with local regulations. 2. Subjects unwilling or unable to comply with study procedures, including consecutive temperature measurements, environmental procedures, or infection control requirements. 3. Conditions that preclude safe or reliable use of the intended measurement sites like Recent rectal surgery, severe hemorrhoids, anal fissures, or other clinical reasons to avoid rectal measurement, recent oral surgery, severe mucosal lesions, inability to cooperate or keep mouth closed as required by IFU, severe dermatologic conditions, burns, open wounds, or other local conditions preventing accurate axillary placement. 4. Acute or chronic conditions likely to interfere with thermoregulation or measurement accuracy (for example, severe sepsis, shock, uncontrolled endocrine disorders, active heat stroke or hypothermia syndromes). Use of medications or interventions that significantly alter body temperature within the pre-specified window (for example, antipyretic medication within 6 hours prior to measurement, active external cooling/heating devices, or recent administration of intravenous antipyretics/thermoregulatory agents). 5. Participation in another investigational drug or device study within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Investigational (Dr Morepen DigiClassic MT-110) versus reference (Omron MC-246) measurements within 0.2 C for IFU aligned clinical datasets and ISO 80601-2-56:2017.Timepoint: Visit 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion within 0.1 C in 35.5 42.0 C; within-subject SD; ICC; Bland Altman mean bias & LoA; first attempt success; IFU timing; device deficienciesTimepoint: Visit 1 | — |
Countries
India
Contacts
Public ContactSyed Atif Hussain
Strider Lifesciences Pvt Ltd
Outcome results
None listed