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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-17

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Melanoma (Skin) Basal Cell Carcinoma Squamous Cell Carcinoma Dysplastic Nevus Syndrome Lentigo Maligna Seborrheic Keratosis Lichen Planus-Like Keratosis Carcinosarcoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Control

Individuals without skin damage (melanoma, BCC, SCC, etc)

Electrical Impedence Spectroscopy DermaSense

Intervention Type DIAGNOSTIC_TEST

Two sets of measurements will be performed to each subject, either at a nevus in contrast with a nearby clear patch of skin. The duration of each measurement will last for approximately 1.5 minutes and the excel file will be directly available to researcher, allowing him/her for data storage and data visualization.

Skin lesion

Individuals diagnosed with confirmed skin damage by Dermatologists

Electrical Impedence Spectroscopy DermaSense

Intervention Type DIAGNOSTIC_TEST

Two sets of measurements will be performed to each subject, either at a nevus in contrast with a nearby clear patch of skin. The duration of each measurement will last for approximately 1.5 minutes and the excel file will be directly available to researcher, allowing him/her for data storage and data visualization.

Interventions

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Electrical Impedence Spectroscopy DermaSense

Two sets of measurements will be performed to each subject, either at a nevus in contrast with a nearby clear patch of skin. The duration of each measurement will last for approximately 1.5 minutes and the excel file will be directly available to researcher, allowing him/her for data storage and data visualization.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Male or female at least 8 years old
* Individuals diagnosed with confirmed skin damage by Dermatologists
* Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi), so necessitating a biopsy.
* The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated
* Participant himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent
* Participants under 18 years old must have a parent, or / and other reliable caregiver who agrees to accompany him/her to the measurements, provide information about the participant as required by the protocol

* Male or female at least 8 years old
* Matched healthy control population: Individuals without skin damage (melanoma, BCC, SCC, etc) that have been included in cohort.
* Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi), so necessitating a biopsy.
* The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated
* Participant himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent
* Participants under 18 years old must have a parent, or / and other reliable caregiver who agrees to accompany him/her to the measurements, provide information about the participant as required by the protocol

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes