Clinical trial · Observational
Study of the Nevisense Device to Assess Atypical Skin Lesions
Performance of Nevisense Electrical Impedance Spectroscopy in Patients With Multiple Nevi and Large Acquired Nevi (LAN)
NCT04705168CI-TRIAL-00097608completedClinicalTrials.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 study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma. Assessing particpants' moles with the Nevisense device may help improve screening methods for the early detection of melanoma in people with atypical mole syndrome.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large Acquired Nevi | — | UNRESOLVED | — |
| Multiple Nevi | — | UNRESOLVED | — |
| Nevus | Nevus | ONTOLOGY_EXACT | 0.98 |
| Skin Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nevisense electrical impedance spectroscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants displaying nevi
- description
- Participants displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study.
- interventionNames
- Diagnostic Test: Nevisense electrical impedance spectroscopy
Primary outcomes (1)
- measure
- Electrical impedance spectroscopy scores of participants' nevi
- timeFrame
- 2 weeks
- description
- The primary objective is to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\> 30 years of age) at the time of the initial study visit. * Patients displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study. * Patients with at least three clinically stable nevi between 5 and 20 mm in diameter. * Patients (or LAR) who are able to provide informed consent. * Patients with previous total body photography images taken at least 3 years prior Exclusion Criteria: * Patients without at least three clinically stable nevi between 5 and 20 mm in diameter. * Patients with any electronic implantable devices. * Patients who are pregnant (verbally confirmed with the participant).
References
Publications (0)
Data not yet available
No reference posted for this study.