SCT02 Clinical Accuracy Validation

NCT06637878 | Completed Results FDA Device

• 1 other identifier: WIBOFE
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Fever

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Febrile - Investigational Device

EXPERIMENTAL

Temperature recording of patient with fever with investigational device

Device: Investigational Device (Withings SCT02) temporal thermometer measurement

Febrile - Comparator

ACTIVE COMPARATOR

Temperature recording of patient with fever with predicate device

Device: Reference Device (Withings SCT01) temperature measurement

Interventions

Investigational Device (Withings SCT02) temporal thermometer measurement DEVICE

temperature measurement with investigational device (Withings SCT02)

Febrile - Investigational Device

Reference Device (Withings SCT01) temperature measurement DEVICE

temperature measurement with reference device (Withings SCT01)

Febrile - Comparator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Withings: lead

Study Sites (5)

Diverse Clinical Research

Miami, Florida, 33175, United States

Location

Dragonfly Primary Care

Indianapolis, Indiana, 46237, United States

Location

New York City Health and Hospitals Corporation

New York, New York, 10029, United States

Location

Integrated Family Care

Cincinnati, Ohio, 45206, United States

Location

SES

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Per ISO 80601-2-56, there are no established acceptance criteria; Quantities are reported for the BeamO device without judgment as to whether the results are acceptable or unacceptable.

Results Point of Contact

• Title: Aline Criton
• Organization: Withings

clinicaltrials-us@withings.com

+33 1.41.46.04.60

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 3, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 8, 2025
• Last Updated: June 5, 2026
• Results First Posted: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)