Clinical trial · Interventional
Clinical Utility of Electrical Impedance Spectroscopy
Evaluation of the Clinical Utility of Electrical Impedance Spectroscopy in Normal Clinical Practice at Hospital Setting
NCT04161742CI-TRIAL-00041611unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement at time of biopsy decision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Focus of Study: Patients With Suspicion of Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nevisense | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number needed to biopsy
- timeFrame
- 1 day
- description
- The primary study outcome is the number needed to biopsy to detect a single melanoma case.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * The lesion(s) meet criteria for Nevisense evaluation. * Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy. * Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on: * primary skin lesions with a diameter between 2 mm and 20 mm; * lesions that are accessible by the Nevisense probe; * lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions); * lesions that do not contain a scar or fibrosis consistent with previous trauma; * lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions; * lesions not in hair-covered areas; * lesions which do not contain foreign matter; * lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas). Exclusion Criteria: * Subjects who fail to provide informed consent * Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data
References
Publications (2)
- 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
- BACKGROUNDRocha L, Menzies SW, Lo S, Avramidis M, Khoury R, Jackett L, Guitera P. Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions. Br J Dermatol. 2017 Nov;177(5):1432-1438. doi: 10.1111/bjd.15595. Epub 2017 Oct 11. PMID 28421597