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The aim of the study is to validate the accuracy of the temporal thermometer of Withings SCT02
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febrile - Investigational Device | Experimental | Temperature recording of patient with fever with investigational device |
|
| Febrile - Comparator | Active Comparator | Temperature recording of patient with fever with predicate device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Device (Withings SCT02) temporal thermometer measurement | Device | temperature measurement with investigational device (Withings SCT02) |
|
| 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 |
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Inclusion Criteria
Exclusion Criteria
Personnel: An employee of the sponsor or the study site or members of their immediate family.
Medical Condition:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diverse Clinical Research | Miami | Florida | 33175 | United States | ||
| Dragonfly Primary Care |
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Recruitment occurred at 5 clinical sites in the US from 8/31/2024 to 12/20/2024
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| ID | Title | Description |
|---|---|---|
| FG000 | Febrile - Investigational Device and Comparator | Temperature recording of patient with temperature of 100.4 degrees F or more with predicate device and investigational device |
| FG001 | Afebrile - Investigational Device and Comparator | Temperature recording of patient with temperature of up to100.3 degrees F with predicate device and investigational device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
11 protocol deviations leading to exclusion of participants from the efficacy analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Febrile - Investigational Device and Comparator | Temperature recording of patient with temperature of 100.4 degrees F or more with predicate device and investigational device |
| BG001 | Afebrile - Investigational Device and Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Degrees Fahrenheit | 1 visit |
|
|
For the duration of the study visit (up to 1 hour)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Device | Predicate device used for temperature measurement | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aline Criton | Withings | +33 1.41.46.04.60 | clinicaltrials-us@withings.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2024 | Apr 15, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Reference Device (Withings SCT01) temperature measurement | Device | temperature measurement with reference device (Withings SCT01) |
|
| Indianapolis |
| Indiana |
| 46237 |
| United States |
| New York City Health and Hospitals Corporation | New York | New York | 10029 | United States |
| Integrated Family Care | Cincinnati | Ohio | 45206 | United States |
| SES | Mason | Ohio | 45040 | United States |
Temperature recording of patient with temperature of up to100.3 degrees F with predicate device and investigational device
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Sex/Gender were not collected from any participant. | Data was not collected in CRF about subject sex/gender | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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|
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| Primary | 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. | Posted | Number | Degrees Fahrenheit | 1 visit |
|
|
|
| Primary | 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. | Posted | Number | Degrees Fahrenheit | 1 visit |
|
|
|
| 118 |
| 0 |
| 118 |
| 0 |
| 118 |
| EG001 | Investigational Device | Investigational device used for temperature measurement | 0 | 118 | 0 | 118 | 0 | 118 |
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