Focus of the Report: The focus of this Health Technology Assessment is evaluation of the effectiveness and safety of electrical impedance spectroscopy (EIS) as an adjunct to conventional clinical examination alone or combined with dermoscopy for diagnosis of cutaneous melanoma in patients who have suspicious skin lesions.
Technology Description: EIS is measured with the Nevisense™ device that uses a handheld probe connected to a small base unit. The end of the probe contains a disposable electrode with numerous tiny pins to apply the electric current. EIS is measured automatically with 35 different frequencies of alternating current that are rapidly analyzed by the device to calculate an EIS score ranging from 0 to 10. Higher scores indicate greater risk and a score ≥ 4 is considered positive for melanoma.
Controversy: Cutaneous melanoma is a serious cancer, with the potential for metastasis. Skin biopsies are usually easily obtained and often so small that no suture is necessary. For situations in which the need for biopsy is uncertain or undesirable, the clinical role of EIS is unclear since it has not been adequately evaluated relative to dermoscopy.
Is EIS accurate as an adjunct to clinical examination for the diagnosis of cutaneous melanoma in patients who have suspicious skin lesions (clinical validity)?
How does adjunct use of EIS compare with conventional techniques for diagnosis of cutaneous melanoma, and does its addition improve treatment decision-making and health outcomes (clinical utility)?
Is EIS safe for the diagnosis of cutaneous melanoma in patients who have suspicious skin lesions?
Have definitive patient selection criteria been identified for EIS for the diagnosis of cutaneous melanoma in patients who have suspicious skin lesions?
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