N/A
N=111
Comparison Study of Core Temperature Thermometry Systems
Thermometry Device Comparisons
Bottom Line
View on ClinicalTrials.gov: NCT01255865 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Temperature Agreement in Degrees Celsius. — NA; 0.5; 0.5; 0.4 Temperature in Celsius
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- 3M
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature Agreement in Degrees Celsius. |
NA; 0.5; 0.5; 0.4; 0.5; 0.3 | — |
Summary
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.
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.