Trial Outcomes & Findings for SCT02 Clinical Accuracy Validation (NCT NCT06637878)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

1 visit

Results posted on

2026-06-05

Participant Flow

Recruitment occurred at 5 clinical sites in the US from 8/31/2024 to 12/20/2024

Participant milestones

Participant milestones
Measure	Febrile - Investigational Device and Comparator Temperature recording of patient with temperature of 100.4 degrees F or more with predicate device and investigational device	Afebrile - Investigational Device and Comparator Temperature recording of patient with temperature of up to100.3 degrees F with predicate device and investigational device
Overall Study STARTED	36	82
Overall Study COMPLETED	36	81
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was not collected in CRF about subject sex/gender

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Febrile - Investigational Device and Comparator n=33 Participants Temperature recording of patient with temperature of 100.4 degrees F or more with predicate device and investigational device	Afebrile - Investigational Device and Comparator n=74 Participants Temperature recording of patient with temperature of up to100.3 degrees F with predicate device and investigational device	Total n=107 Participants Total of all reporting groups
Age, Customized 0 to <3 months	0 Participants n=33 Participants	15 Participants n=74 Participants	15 Participants n=107 Participants
Age, Customized ≥3 months to <1 year	11 Participants n=33 Participants	10 Participants n=74 Participants	21 Participants n=107 Participants
Age, Customized ≥1 to <5 years	11 Participants n=33 Participants	25 Participants n=74 Participants	36 Participants n=107 Participants
Age, Customized ≥5 years	11 Participants n=33 Participants	24 Participants n=74 Participants	35 Participants n=107 Participants
Sex/Gender, Customized Not Collected	0 Participants Data was not collected in CRF about subject sex/gender	0 Participants Data was not collected in CRF about subject sex/gender	0 Participants Data was not collected in CRF about subject sex/gender
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Patients n=106 Participants Results of accuracy of all temperature recordings with investigational device as compared to predicate devices
Clinical Bias	-0.074 Degrees Fahrenheit Standard Deviation 0.5115

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Patients n=106 Participants Results of accuracy of all temperature recordings with investigational device as compared to predicate devices
Limits of Agreement	1.023 Degrees Fahrenheit

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Patients n=106 Participants Results of accuracy of all temperature recordings with investigational device as compared to predicate devices
Clinical Repeatability	0.29 Degrees Fahrenheit

Adverse Events

Reference Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Investigational Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aline Criton

Withings

Phone: +33 1.41.46.04.60

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place