N/A
N=110
Clinical Accuracy of the welloStationX
Fever
Bottom Line
View on ClinicalTrials.gov: NCT03758157 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Clinical Agreement Through Clinical Bias Evaluation — 0.04 degrees Farehheit
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- welloStationX (Diagnostic_test); SureTemp (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Wello Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Agreement Through Clinical Bias Evaluation |
0.04 | — |
| SECONDARY Clinical Repeatability |
0.062 | — |
Summary
This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.
Eligibility Criteria
Inclusion Criteria
- Male or female.
- 5 years and up.
- Signed informed consent form.
Exclusion Criteria
- Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test.
- immunization within seven days of the test
Data sourced from ClinicalTrials.gov (NCT03758157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.