Malignant Melanoma
Conditions
Brief summary
This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study \[IMATS\]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.
Interventions
Following enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe.
Sponsors
SciBase AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women of any ethnic group * Lesion located on normal healthy skin * Maximum number of eight lesions per patient * etc.
Exclusion criteria
* Lesion under finger and toe nails * Lesion located on eczema, psoriasis areas or similar * Lesion located on scars * etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measure not applicable. This is an algorithm training study. | Q1 2010 |
Countries
Sweden
Outcome results
None listed