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

NCT06690086 | Completed FDA Device

• 1 other identifier: CSP-18-0002
• Study Type: observational
• Target: 1,028
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer

Keywords

Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Elastic Scattering Spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%

  Day 1

Study Arms (1)

Subjects with skin lesions suggestive of skin cancer

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.

Procedure: Lesion biopsy; Device: DermaSensor Device Use

Interventions

Lesion biopsy PROCEDURE

Lesions enrolled in the study are biopsied to confirm histopathology

Subjects with skin lesions suggestive of skin cancer

DermaSensor Device Use DEVICE

Users are blinded to the DermaSensor Device result

Subjects with skin lesions suggestive of skin cancer

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men or women of any ethnic group aged 22 and older with at least one skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy.

You may qualify if:

• Men or women of any ethnic group aged 22 and older
• Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
• Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)

You may not qualify if:

• Lesion \< 2.5mm in diameter or \> 15mm in diameter
• Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
• Lesion on area of crust, psoriasis, eczema or similar skin condition
• Lesion has erosion and/or ulceration with no area \>2.5mm intact
• Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
• Lesion in which the device tip cannot be placed entirely within the border of the targeted area
• Lesion located on acral skin (e.g. sole or palms)
• Lesion located within 1 cm of the eye
• Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
• Lesion located on mucosal surfaces (e.g. genitals, lips)
• Lesion located on acute sunburn
• Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy
• Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent

Sponsors & Collaborators

• DermaSensor, Inc.: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Melanoma; Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Study Officials

• Stephen P Merry, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: August 17, 2020
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)