Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage

Terminated

• Conditions: Squamous Cell Carcinoma; Carcinosarcoma; Melanoma (Skin); Basal Cell Carcinoma; Lichen Planus-Like Keratosis; Dysplastic Nevus Syndrome; Lentigo Maligna; Seborrheic Keratosis
• Interventions: Diagnostic Test: Electrical Impedence Spectroscopy DermaSense

• Registration Number: NCT04688749
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The purpose of this clinical study is to evaluate if the DermaSense prototype EIS scanner can provide medical decision support which can complement dermoscopy-based identification of the disease at time of biopsy decision.

Detailed Description

This is a clinical study designed to evaluate if the DermaSense device can be a system of an automated analysis and classification of skin lesions aiming to provide a comprehensive, reliable and cost-effective approach to assist the Dermatologists' decision (biopsy, dermoscopy, histopathological analysis etc). The study enrollment will continue until a minimum of 180 subjects are enrolled in the study. Second Department of Dermatology, School of Medicine, Faculty of Health Sciences of the Aristotle University of Thessaloniki, at the "Papageorgiou" General Hospital will participate in this study. Dermatologists participating in the study will perform the patient and lesion assessment for biopsy as standard of care at the clinic.

EIS (electrical impedance spectroscopy) measurements will be done once per participant recommended by the Dermatologist based on their clinical interest in various areas of the skin. Two sets of measurements will be performed for each participant, either at a nevus in contrast with a nearby clear patch of skin, or at a skin damage area (melanoma, basal cell carcinoma (BCC), squamous cell carcinoma (SCC), etc) in contrast with a nearby clear patch of skin. Also, more repeated measurements may be needed to determine the validity of the measurement result. Evaluation and analysis of the measurement data will be done by the DermaSense team and will be used not only for applying appropriate statistical correlations compared to established dermatological diagnostic methods (eg dermοscopy, histopathological examinations, biopsies etc.) but also for training in artificial intelligence and machine learning methods. Finally, the participants will sign a consent form that is consistent with bioethical rules and according with EU GDPR regulation to protect their personal data.

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• concurrent participation in another relevant study
• occurrence of skin damage during the study
• Subjects who fail to provide informed consent
• Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit DermaSense prototype EIS scanner from collecting data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control	Electrical Impedence Spectroscopy DermaSense	Individuals without skin damage (melanoma, BCC, SCC, etc)
Skin lesion	Electrical Impedence Spectroscopy DermaSense	Individuals diagnosed with confirmed skin damage by Dermatologists

Primary Outcome Measures

Name	Time	Method
Comparison of Dermasense measurements	2 weeks	Use of DermaSense prototype EIS scanner in detecting significant electrical impedance differences between malignant and benign skin lesions.
Electrical impedance spectroscopy (EIS) measurements	1 day	Use of DermaSense prototype EIS scanner in measuring Electrical Impedance Spectroscopy (EIS) at 10 different frequencies in skin of various body surfaces.

Secondary Outcome Measures

Name	Time	Method
Decision support system	5 months	Setting DermaSense prototype EIS scanner in clinical diagnosis of skin lesions, or at least as a potential decision support tool to more accurately identify skin lesions for surgical excision and histopathologic evaluation.

Trial Locations

Locations (1)

Laboratory of Medical Physics, AUTH; 🇬🇷 Thessaloniki, Greece