C43
Conditions
Interventions
Group 1: Patients with suspected malignant melanoma are examined once before the planned surgical removal of a suspicious lesion. This involves photodocumentation and dermoscopic imaging of the suspic
Sponsors
Magnosco GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: at least 18 years old, skin lesion suspected to be malignant melanoma, planned histological analysis of skin lesion to be excised, skin type I–IV (Fitzpatrick), informed about the aims and the character of the study, written informed consent for the participation in the study, suspected lesion is not injured, not bleeding, not ulcerating and can be reached by the measurement device, Suspect can remain still for 30 minutes
Exclusion criteria
Exclusion criteria: minors, skin lesion not suspected to be malignant melanoma, breast feeding women or women with known pregnancy, skin type >IV (Fitzpatrick), injured, bleeding or ulcerating lesion, lesion can not be reached by the measurement device, subjects who cannot make decisions on their own, patients with tremor or inability to remain still for 30 min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At least the same measurement accuracy after application of the newly developed algorithm with reduced measurement time compared to the previously applied algorithm (non-inferiority). | — |
Secondary
| Measure | Time frame |
|---|---|
| An increased measurement accuracy after application of the newly developed algorithm with a shortened measurement time compared to the previously applied algorithm. | — |
Countries
Germany
Contacts
Public ContactMartina Meinke
Charité – Universitätsmedizin Berlin,Department of Dermatology, Venerology and Allergology,Center of Experimental and Applied Cutaneous Physiology (CCP)
Outcome results
None listed