DermaSensor Postmarket Surveillance Study

NCT06666790 | Recruiting FDA Device

• 1 other identifier: CSP-24-0002
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.

Conditions

Melanoma, Skin

Keywords

medical device; skin cancer detection; elastic scattering spectroscopy

Outcome Measures

Primary Outcomes (1)

• Device Sensitivity

  39 months

Study Arms (2)

Clinical assessment only

NO INTERVENTION

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output

Clinical assessment with device output

EXPERIMENTAL

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output

Device: Scan with elastic scattering spectroscopy device to assess risk of malignancy

Interventions

Scan with elastic scattering spectroscopy device to assess risk of malignancy DEVICE

Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare suspicious lesion signature to that of previously scanned lesions with known benign or malignant pathology

Clinical assessment with device output

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women of any ethnic group aged 40 and older
• Primary skin lesion suspicious for melanoma
• Patient is willing and able to read, understand, and sign the informed consent form (ICF)

You may not qualify if:

• Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
• Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
• Lesion is greater than 15mm in diameter at the widest point.
• Lesion has a targeted area less than 2.5mm in diameter where the DermaSensor device tip cannot be placed entirely within the border of the targeted area of the lesion.
• Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
• Lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood).
• Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
• Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine).
• Lesion is located on acral skin (e.g., sole or palms).
• Lesion is located within 10mm of the eye.
• Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
• Lesion is located on mucosal surfaces (e.g. genitals, lips).
• Lesion is located in an area with acute sunburn.
• Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and/or completing any required follow-up visits

Sponsors & Collaborators

• DermaSensor, Inc.: lead

Study Sites (2)

Velocity

New Smyrna Beach, Florida, 32168, United States

RECRUITING

West Clinical Research

Morehead City, North Carolina, 28557, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Gary Slatko, MD, MBA

  DermaSensor, Inc.

  STUDY CHAIR

Central Study Contacts

Justin Frazier, MS

CONTACT

508-776-0044; justin.frazier@dermasensor.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator unaided (i.e., blinded/masked) assessment followed by aided assessment of each lesion's malignancy risk.
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrolled lesions are assessed without and then with the device result as basis for study investigator decision to biopsy or monitor a potentially malignant lesion.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): April 11, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (2)