Clinical trial · Observational
Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Comparative Study of Electrical Impedance Spectroscopy (EIS) Models Against Verified Dermatological Diagnostic Data
NCT04688749CI-TRIAL-00068256DermaSenseterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to COVID-19
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinosarcoma | Carcinosarcoma | ONTOLOGY_EXACT | 0.98 |
| Dysplastic Nevus Syndrome | — | UNRESOLVED | — |
| Lentigo Maligna | Lentigo Maligna | ONTOLOGY_EXACT | 0.98 |
| Lichen Planus-Like Keratosis | Lichen Planus-Like Keratosis | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Seborrheic Keratosis | Seborrheic Keratosis | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrical Impedence Spectroscopy DermaSense | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Healthy Control
- description
- Individuals without skin damage (melanoma, BCC, SCC, etc)
- interventionNames
- Diagnostic Test: Electrical Impedence Spectroscopy DermaSense
- label
- Skin lesion
- description
- Individuals diagnosed with confirmed skin damage by Dermatologists
- interventionNames
- Diagnostic Test: Electrical Impedence Spectroscopy DermaSense
Primary outcomes (2)
- measure
- Comparison of Dermasense measurements
- timeFrame
- 2 weeks
- description
- Use of DermaSense prototype EIS scanner in detecting significant electrical impedance differences between malignant and benign skin lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDApalla Z, Lallas A, Sotiriou E, Lazaridou E, Ioannides D. Epidemiological trends in skin cancer. Dermatol Pract Concept. 2017 Apr 30;7(2):1-6. doi: 10.5826/dpc.0702a01. eCollection 2017 Apr. PMID 28515985
- BACKGROUNDMohr P, Birgersson U, Berking C, Henderson C, Trefzer U, Kemeny L, Sunderkotter C, Dirschka T, Motley R, Frohm-Nilsson M, Reinhold U, Loquai C, Braun R, Nyberg F, Paoli J. Electrical impedance spectroscopy as a potential adjunct diagnostic tool for cutaneous melanoma. Skin Res Technol. 2013 May;19(2):75-83. doi: 10.1111/srt.12008. Epub 2013 Jan 27. PMID 23350668
- BACKGROUNDMalvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19. PMID 24841846