SCT02 Clinical Accuracy Validation (WIBOFE)

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

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

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Device: Investigational Device (Withings SCT02) temporal thermometer measurement; Device: Reference Device (Withings SCT01) temperature measurement

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33175
      • Diverse Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Dragonfly Primary Care
  • New York
    • New York, New York, United States, 10029
      • New York City Health and Hospitals Corporation
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Integrated Family Care
    • Mason, Ohio, United States, 45040
      • SES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Febrile - Investigational Device; Temperature recording of patient with fever with investigational device	Device: Investigational Device (Withings SCT02) temporal thermometer measurement; temperature measurement with investigational device (Withings SCT02)
Active Comparator: Febrile - Comparator; Temperature recording of patient with fever with predicate device	Device: Reference Device (Withings SCT01) temperature measurement; temperature measurement with reference device (Withings SCT01)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	1 visit

Collaborators and Investigators

• Sponsor: Withings

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): January 8, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fever
• Other Study ID Numbers: WIBOFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No