AI-DSMM is a multi-centre prospective clinical study to assess the diagnostic performance of Dermalyser when identifying malignant melanomas in subjects seeking primary care for melanoma-suspected cutaneous lesions.
The results will help us confirm the diagnostic precision of the device and answer at which level our AI can identify malignant melanomas among cutaneous lesions that are assessed in clinical use due to any degree of malignancy suspicion. The primary endpoint will be measured as the true proportion; by testing if the device based on artificial intelligence (AI) gives correct results as compared with the result of the lesion analysis (the final classification by PAD) in at least a certain proportion of the analyses.
As well as confirming diagnostic accuracy, the results of the study will provide us with an increased knowledge and understanding of how digital tools enhanced with artificial intelligence can assist physicians with the right support for an earlier diagnosis of malignant melanoma. The study will also provide insight into the health economic benefits of improved diagnosis support.
In the Spring of 2021 we completed a feasibility study focussed on proving the usability of Dermalyser, and investigating Dermalyser’s usefulness as a diagnostic decision support system in the clinical workflow when diagnosing skin cancer diseases.
The target group consisted of 15 Primary care physicians in Stockholm and Linköping. The study results showed that general practitioners can obtain higher accuracy using Dermalyser as a decision support tool when diagnosing malignant melanoma. The results of the study also demonstrated proof of value from a usability perspective.
We aim to publish the study’s findings and results in the scientific journal Acta Dermato-Venereologica.