FeverWIBOFENCT06637878
SCT02 Clinical Accuracy Validation
A study testing Investigational Device (Withings SCT02) temporal thermometer measurement and Reference Device (Withings SCT01) temperature measurement in people with Fever, run by Withings at 5 sites in United States.
Trial summary
The aim of the study is to validate the accuracy of the temporal thermometer of Withings SCT02 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fever
- What is being tested?
- Investigational Device (Withings SCT02) temporal thermometer measurement and Reference Device (Withings SCT01) temperature measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Oct 2024to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Integrated Family Care
Cincinnati, Ohio, 45206
Dragonfly Primary Care
Indianapolis, Indiana, 46237
SES
Mason, Ohio, 45040
Diverse Clinical Research
Miami, Florida, 33175
New York City Health and Hospitals Corporation
New York, New York, 10029
About this study
Official title: 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
- Conditions
- Fever
- Being tested
- Investigational Device (Withings SCT02) temporal thermometer measurement, Reference Device (Withings SCT01) temperature measurement
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Device (Withings SCT02) temporal thermometer measurementDevice
temperature measurement with investigational device (Withings SCT02)
Reference Device (Withings SCT01) temperature measurementDevice
temperature measurement with reference device (Withings SCT01)
| Study group | Role | What they receive |
|---|---|---|
| Febrile - Investigational Device | Experimental | Temperature recording of patient with fever with investigational device Receives: Device: Investigational Device (Withings SCT02) temporal thermometer measurement |
| Febrile - Comparator | Active comparator | Temperature recording of patient with fever with predicate device Receives: Device: Reference Device (Withings SCT01) temperature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start3 Oct 2024
- Primary completion20 Dec 2024
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637878
- Sponsor's protocol ID
- WIBOFE
- Acronym
- WIBOFE
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Accuracy Validation for the Withings BeamO (SCT02) Smart Thermometer
- ClinicalTrials.gov ID
- NCT06637878
- Acronym / sponsor ID
- WIBOFE / WIBOFE
- Conditions
- Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to validate the accuracy of the temporal thermometer of Withings SCT02
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febrile - Investigational Device | Experimental | Device: Investigational Device (Withings SCT02) temporal thermometer measurementTemperature recording of patient with fever with investigational device |
| Febrile - Comparator | Active comparator | Device: Reference Device (Withings SCT01) temperature measurementTemperature recording of patient with fever with predicate device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Personnel: An employee of the sponsor or the study site or members of their immediate family.
- Medical Condition:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Device (Withings SCT02) temporal thermometer measurementtemperature measurement with investigational device (Withings SCT02) | Device | Febrile - Investigational Device |
| Reference Device (Withings SCT01) temperature measurementtemperature measurement with reference device (Withings SCT01) | Device | Febrile - Comparator |
Primary outcome
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).
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Device (Withings SCT02) temporal thermometer measurement and Reference Device (Withings SCT01) temperature measurement in people with Fever, run by Withings at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Bias (time frame: 1 visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.