Status:
TERMINATED
Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Melanoma (Skin)
Basal Cell Carcinoma
Eligibility:
All Genders
8-90 years
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 ti...
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-...
Eligibility Criteria
Inclusion
- The inclusion criteria for patients in this study are as follows:
- 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
- The inclusion criteria for healthy controls in this study are as follows:
- 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
Exclusion
Key Trial Info
Start Date :
July 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04688749
Start Date
July 17 2019
End Date
December 31 2022
Last Update
July 25 2023
Active Locations (1)
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1
Laboratory of Medical Physics, AUTH
Thessaloniki, Greece