Pilot-Study to evaluate and develop the OFM-System in humans
- Conditions
- Healthy subjects
- Registration Number
- DRKS00013259
- Lead Sponsor
- niversitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 18
1. Age = 18 years to = 50 years
2. Healthy subjects
3. Ability to read, understand and sign informed consent form
1. Pregnancy, nursing period or planned pregnancy
2. Known infectious diseases past or present (HIV, Hepatitis B,C)
3. Coagulation disorder or oral anticoagulation therapy
4. Autoimmune dermatoses
5. Known needle phobia
6. Known wound healing disorder e.g. keloid formation
7. Recurring thromboses or known genetic tendency towards thromboses (e.g. APC resistance)
8. Severe acute and/or chronic disease (judged by investigator).
9. Mental incapability, unwillingness or language barriers, which impede or complicate the understanding of the ICF and the necessay cooperation.
10. Known allergy to plasters or adhesive parts of the OFM-System.
11. Any abnormal, clinically significant Screening result which leads to exclusion as judged by the investigator.
12. Tattoos or damaged skin at the application Areas.
13. Active skin disease e.g. Psoriasis or atopic dermatitis (judged by investigator).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method