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OpenTrials
Completed

NCT Number: NCT06637878

SCT02 Clinical Accuracy Validation

The aim of the study is to validate the accuracy of the temporal thermometer of Withings SCT02

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diverse Clinical Research, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Age: Participant age is among the categories
  • Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.

Exclusion criteria

  • Personnel: An employee of the sponsor or the study site or members of their immediate family.
  • Medical Condition:
  • Preterm infants (current age plus length of gestation is less than 40 weeks)
  • Has taken antipyretic in previous 2 hours
  • Inflammation at the measurement site
  • Medical conditions that affect temperature readings (barbiturates, thyroid, antipsychotics, recent immunizations)

Treatment and study plan

Investigational Device (Withings SCT02) temporal thermometer measurement

Device

temperature measurement with investigational device (Withings SCT02)

Reference Device (Withings SCT01) temperature measurement

Device

temperature measurement with reference device (Withings SCT01)

Primary outcomes

  1. Clinical Bias

    Time frame: 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).

  2. Limits of Agreement

    Time frame: 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.

  3. Clinical Repeatability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Official study title

Clinical Accuracy Validation for the Withings BeamO (SCT02) Smart Thermometer

Acronym: WIBOFE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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