The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: * Ruler using the Kundin method, * Investigational software Clinicgram Euclides * Digital planimetry with Adobe Photoshop The clinical data retrieved in this study will allow the clinical validation of the safety and safety of the investigation software Clinicgram Euclides.
The aim of the clinical investigation EUCLIDES-01 is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three skin lesion area measurement methods: * Ruler using the Kundin method, * Investigational software Clinicgram Euclides * Digital planimetry with Adobe Photoshop Clinicgram Euclides is a software that allows automatic calculation of skin lesion areas using a mobile device. It has two modes of operation (Euclides 2D and Euclides 3D). The sample size is 65 subjects. Up to three skin lesions can be included from the same subject. For this reason, the number of subjects may be smaller if more than one skin lesion is measured in certain subjects. EUCLIDES-01 is a pre-market, prospective, single-center, non-randomized clinical investigation with one arm of subjects intended to collect skin lesion area data for the comparison of the agreement among the results obtained between the three above-mentioned skin lesion area measurement methods. No patient follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
65
Clinicgram Euclides is a software that allows automated calculation of the area of skin lesions using a mobile device. Three different photographs will be taken of the subject's skin lesion. The area of the skin lesion will be calculated using the photograph of the skin lesion, and: * for EUCLIDES 2D, an external marker. The investigator will outline the skin lesion and the external marker in the photograph prior to the calculation of the skin lesion area. * for EUCLIDES 3D, a two reference points selected by the investigator.
Skilled Skin S.L.
Barcelona, Spain
Agreement of the skin lesion area measurements between two methods of routine clinical practice and the investigational software Clinicgram Euclides.
To assess the agreement/concordance of skin lesion area measurements between: * the investigational software Clinicgram Euclides and digital planimetry using Adobe Photoshop, and * the investigational software Clinicgram Euclides and the ruler measurement using the Kundin method.
Time frame: 1 day
Reproducibility of Clinicgram Euclides in the automatic calculation of skin lesion areas using different mobile devices.
To assess the reproducibility of Clinicgram Euclides in the e of skin lesion area measurements using two different mobile devices: an iPhone and an iPad.
Time frame: 1 day
Repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two measurements performed by the same investigator.
To assess the repeatability of Clinicgram Euclides in the automatic calculation of skin lesion areas between two consecutive measurements performed by the same investigator.
Time frame: 1 day
Usability of the investigational software Clinicgram Euclides.
To evaluate the usability of the investigational software Clinicgram Euclides based on the completion of a usability questionnaire by each investigator who has used Clinicgram Euclides throughout the clinical investigation, and on the assessment of the time required to complete the calculation of the skin lesion area with each of the 3 methods (ruler measurement using Kundin method, investigational software Clinicgram Euclides, and digital planimetry using Adobe Photoshop).
Time frame: 1 day (at the end of the study)
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