Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage (NCT04688749) | Clinical Trial Compass
TerminatedNot Applicable
Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Stopped: Due to COVID-19
Greece50 participantsStarted 2019-07-17
Plain-language 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.
Who can participate
Age range
8 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.