Clinical trial · Observational
DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)
NCT06690086CI-TRIAL-00083486DERM-SUCCESScompletedClinicalTrials.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 evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DermaSensor Device Use | Device | — | UNRESOLVED |
| Lesion biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects with skin lesions suggestive of skin cancer
- description
- Subjects with primary skin lesion(s) suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess the DermaSensor device accuracy in determining risk of malignancy.
- interventionNames
- Procedure: Lesion biopsy
- Device: DermaSensor Device Use
Primary outcomes (2)
- measure
- Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
- timeFrame
- Day 1
- measure
- Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
- timeFrame
- Day 1
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men or women of any ethnic group aged 22 and older 2. Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy 3. Patient is willing and able to read, understand and sign the Informed Consent Form (ICF) Exclusion Criteria: 1. Lesion \< 2.5mm in diameter or \> 15mm in diameter 2. Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale) 3. Lesion on area of crust, psoriasis, eczema or similar skin condition 4. Lesion has erosion and/or ulceration with no area \>2.5mm intact 5. Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions) 6. Lesion in which the device tip cannot be placed entirely within the border of the targeted area 7. Lesion located on acral skin (e.g. sole or palms) 8. Lesion located within 1 cm of the eye 9. Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention 10. Lesion located on mucosal surfaces (e.g. genitals, lips) 11. Lesion located on acute sunburn 12. Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy 13. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.