DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer

Completed

• Conditions: Skin Cancer

• Registration Number: NCT06690086
• Lead Sponsor: DermaSensor, Inc.

Brief Summary

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.

Detailed Description

A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.

Study Timeline

• Study Start: 2020-08-17
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1028

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC	Day 1
Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC	Day 1

Secondary Outcome Measures

Name	Time	Method
Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%	Day 1

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States