DermaSensor Postmarket Surveillance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2027-09-10

Brief Summary

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

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Detailed Description

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Conditions

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Melanoma, Skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Investigator unaided (i.e., blinded/masked) assessment followed by aided assessment of each lesion's malignancy risk.

Study Groups

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Clinical assessment only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Clinical assessment with device output

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

Group Type EXPERIMENTAL

Scan with elastic scattering spectroscopy device to assess risk of malignancy

Intervention Type 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

Interventions

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Scan with elastic scattering spectroscopy device to assess risk of malignancy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
2. Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
3. Lesion is greater than 15mm in diameter at the widest point.
4. 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.
5. Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
6. 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).
7. Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
8. 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).
9. Lesion is located on acral skin (e.g., sole or palms).
10. Lesion is located within 10mm of the eye.
11. Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
12. Lesion is located on mucosal surfaces (e.g. genitals, lips).
13. Lesion is located in an area with acute sunburn.
14. 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No