Clinical trial · Observational
Development and Validation of a New Digital Dermatoscope in the United States
NCT04047316CI-TRIAL-00045590completedClinicalTrials.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)
A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.
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 |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital dermoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Performance of the new device in its normal conditions of use
- timeFrame
- 6 months
- description
- The outcome will be measured by a questionnaire with performance-related questions for clinicians to answer about a set of images from the collected database. A Likert-based scale will be used for the answers: from highly agree to highly disagree.
- measure
- Usability of the new device
- timeFrame
- 1 month
- description
- The outcome will be measured by a questionnaire with usability-related questions for clinicians.
- measure
- Safety of the new device in its normal conditions of use
- timeFrame
- 1 year
- description
- The number of adverse events will be reported to assess safety of the device.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * Male or Female, aged less than 18 years, with informed consent of their legally authorized representative. * Patient presenting with any visible skin lesion for dermatologist review on a body site amenable to optimal photographic imaging. * Able and willing to comply with all study requirements. * Patient with a skin lesion that is clinically diagnosed by a dermatologist as benign, malignant or a suspicious skin lesion requiring excisional biopsy for histological diagnosis. Exclusion Criteria: * Patients aged under 18 years old where the legally authorized representative is unable or unwilling to provide their informed consent. * Patients unable to provide informed consent. * Skin lesions in an anatomical site which is not suitable for photography including hair-obscured site, subungual lesion or inaccessible mucosal site. * Lesion is at a site where previous surgery was undertaken.
References
Publications (0)
Data not yet available
No reference posted for this study.