Healthy Volunteer
Conditions
Interventions
Group 1: At each subject a reference clinical thermometer (TcoreTM temperature monitoring system ) will be applied connected toa Dräger monitor.In addition a MedTemp sensor is fixed in each armpit con
Sponsors
SteadySense GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-65 years (both inclusive) 2. Signed Informed Consent Form before study related activities 3. BMI between 22 and 29kg/m² (both inclusive) for 15 subjects 4. BMI = 30 kg/m² for 15 subjects
Exclusion criteria
Exclusion criteria: 1. Severe acute and/or chronic disease (judged by the investigator) 2. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation 3. Skin diseases which may influence the study results (judged by the investigator) 4. Pregnancy, breast feeding or intention of becoming pregnant 5. Any disease or condition which the investigator or the acting physician feels would interfere with the trial or the safety of the subject 6. Known allergies against skin patch or its components 7. Other conditions that make participation in the clinical trial impossible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the limits of agreement of axillary continous temeperature sensors compared to Reference thermometer in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of usability and saftey of axillary continous temperature sensors in healthy subjects. Usability will be measured by: - Number of sensor values per subject - Number of sensor values per sensor - Number of sensor removal (durability) - Number of sensors per subject Safety will be measured by: - Medical History - Concomitant Medication - Saftey lab parameters - Adverse Events - Adverse Device Effects - Vital Signs | — |
Countries
Austria
Contacts
Public ContactStefan Korsatko
Medizinische Universität Graz, Clinical Research Center
Outcome results
None listed