STUDY TO EVALUATE THE FINAL DEVELOPMENT IF THE OFM-SYSTEM IN HUMANS

STUDY TO EVALUATE THE FINAL DEVELOPMENT IF THE OFM-SYSTEM IN HUMANS - CAPPS_FIN

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017181

Enrollment

Registered

2019-04-17

Start date

2019-04-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Group 1: Sampling of dermal interstitial fluid for 30 hours using the OFM-System (Open Microperfusion) with different operation-parametres.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years to = 50 years 2. Healthy subjects 3. Ability to read, understand and sign informed consent form

Exclusion criteria

Exclusion criteria: 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 necessary cooperation. 10. Known allergy to plasters or adhesive parts of the OFM-System. 11. Any abnormal, clinically significant Screening results 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).

Design outcomes

Primary

Measure	Time frame
Functionality and Efficiency of the OFM-System for the duration of 30 hours. Objectively measured via sample-volume gained [µL, comparison of mean values ± Standard deviation] in reliance on operation parametres.	—

Secondary

Measure	Time frame
Objectively measured as sample-volume stability for the fractions/time via coefficient of variation [% coefficient of variation, comparison of mean values ± Standard deviation] in reliance on operation parametres. Objectively measured as glucose-recovery stability relative to blood glucose for the fractions/time via coefficient of variation [% coefficient of variation, comparison of mean values ± Standard deviation] in reliance on operation parametres.	—

Measure

Time frame

Objectively measured as sample-volume stability for the fractions/time via coefficient of variation [% coefficient of variation, comparison of mean values ± Standard deviation] in reliance on operation parametres. Objectively measured as glucose-recovery stability relative to blood glucose for the fractions/time via coefficient of variation [% coefficient of variation, comparison of mean values ± Standard deviation] in reliance on operation parametres.

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Countries

Austria

Contacts

Public ContactGerd Schwagerle

Medizinische Universität Graz,Clinical Research Center

gerd.schwagerle@medunigraz.at+4331638572834

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026