Fever
Conditions
Brief summary
The aim of the study is to validate the accuracy of the temporal thermometer of Withings SCT02
Interventions
DEVICEInvestigational Device (Withings SCT02) temporal thermometer measurement
temperature measurement with investigational device (Withings SCT02)
DEVICEReference Device (Withings SCT01) temperature measurement
temperature measurement with reference device (Withings SCT01)
Sponsors
Withings
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Age: Participant age is among the categories 3. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
1. Personnel: An employee of the sponsor or the study site or members of their immediate family. 2. Medical Condition: 1. Preterm infants (current age plus length of gestation is less than 40 weeks) 2. Has taken antipyretic in previous 2 hours 3. Inflammation at the measurement site 4. Medical conditions that affect temperature readings (barbiturates, thyroid, antipsychotics, recent immunizations)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Bias | 1 visit | Mean of the per-subject differences (Investigational - Reference), computed using the first measurement obtained from each subject with each device. A bias closer to 0 °F indicates closer agreement between devices; the sign indicates direction (a negative value means the investigational device read lower, on average, than the reference). |
| Limits of Agreement | 1 visit | Defined per ISO (International Standards Organization) 80601-2-56 as 2 × the standard deviation of the per-subject (Investigational - Reference) differences. A smaller value indicates tighter agreement between the two devices around the mean bias. |
| Clinical Repeatability | 1 visit | Pooled standard deviation of three repeated measurements taken on the same subject with the investigational device, calculated as σr = √\[(σ1² + σ2² + … + σN²) / N\], where σi is the within-subject standard deviation of the three repeats for subject i and N is the number of subjects with repeated measurements. A smaller value (closer to 0 °F) indicates greater consistency of repeated measurements on the same subject. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred at 5 clinical sites in the US from 8/31/2024 to 12/20/2024
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 0 to <3 months | 15 Participants |
| Age, Customized ≥1 to <5 years | 25 Participants |
| Age, Customized ≥3 months to <1 year | 10 Participants |
| Age, Customized ≥5 years | 24 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex/Gender, Customized Not Collected | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 118 |
| other Total, other adverse events | 0 / 118 | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 | 0 / 118 |
Outcome results
None listed