An interventional study of Investigational Device (Withings SCT02) temporal thermometer measurement and Reference Device (Withings SCT01) temperature measurement in Fever, sponsored by Withings. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Withings · Not applicable, Interventional, and Basic science
The aim of the study is to validate the accuracy of the temporal thermometer of Withings SCT02
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's enrollment of 118 is close to the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Withings is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Medical Condition:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Temperature recording of patient with fever with investigational device
Device: Investigational Device (Withings SCT02) temporal thermometer measurement
Temperature recording of patient with fever with predicate device
Device: Reference Device (Withings SCT01) temperature measurement
temperature measurement with investigational device (Withings SCT02)
temperature measurement with reference device (Withings SCT01)
Clinical Bias
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).
Time frame: 1 visit
Limits of Agreement
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.
Time frame: 1 visit
Clinical Repeatability
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.
Time frame: 1 visit
Recruitment occurred at 5 clinical sites in the US from 8/31/2024 to 12/20/2024
| Milestone | Febrile - Investigational Device and Comparator | Afebrile - Investigational Device and Comparator |
|---|---|---|
| Started | 36 | 82 |
| Completed | 36 | 81 |
| Not completed | 0 | 1 |
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).
| Degrees Fahrenheit | All Patients |
|---|---|
| Clinical Bias | -0.074 ± 0.5115 |
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.
| Degrees Fahrenheit | All Patients |
|---|---|
| Limits of Agreement | 1.023 |
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.
| Degrees Fahrenheit | All Patients |
|---|---|
| Clinical Repeatability | 0.29 |
Collected over For the duration of the study visit (up to 1 hour). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reference Device | 0/118 (0%) | 0/118 (0%) | 0/118 (0%) |
| Investigational Device | 0/118 (0%) | 0/118 (0%) | 0/118 (0%) |
11 protocol deviations leading to exclusion of participants from the efficacy analysis
| Age, Customized(Participants) | Febrile - Investigational Device and Comparator | Afebrile - Investigational Device and Comparator | Total |
|---|---|---|---|
| 0 to <3 months | 0 | 15 | 15 |
| ≥3 months to <1 year | 11 | 10 | 21 |
| ≥1 to <5 years | 11 | 25 | 36 |
| ≥5 years | 11 | 24 | 35 |
| Sex/Gender, Customized(Participants) | Febrile - Investigational Device and Comparator | Afebrile - Investigational Device and Comparator | Total |
|---|---|---|---|
| Not Collected | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Febrile - Investigational Device and Comparator | Afebrile - Investigational Device and Comparator | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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