N/A
Completed N=111
Comparison Study of Core Temperature Thermometry Systems
Thermometry Device Comparisons
Source: ClinicalTrials.gov NCT01255865 ↗
Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Temperature Agreement in Degrees Celsius. — NA; 0.5; 0.5; 0.4 Temperature in Celsius
Summary
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature Agreement in Degrees Celsius. |
NA; 0.5; 0.5; 0.4; 0.5; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
-
Exclusion Criteria
- Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization
Data sourced from ClinicalTrials.gov (NCT01255865). 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. Informational only — not medical advice.