RECRUITING

DermaSensor Postmarket Surveillance Study

Conditions

Melanoma, Skin medical device skin cancer detection elastic scattering spectroscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

DermaSensor Postmarket Surveillance Study

Quick Facts

Study Start:2024-10-08

Study Completion:2027-09-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06666790

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Contact

Justin Frazier, MS

CONTACT

508-776-0044

justin.frazier@dermasensor.com

Principal Investigator

Gary Slatko, MD, MBA

STUDY_CHAIR

DermaSensor, Inc.

Study Locations (Sites)

Velocity

New Smyrna Beach, Florida, 32168

United States

West Clinical Research

Morehead City, North Carolina, 28557

United States

Collaborators and Investigators

Sponsor: DermaSensor, Inc.

Gary Slatko, MD, MBA, STUDY_CHAIR, DermaSensor, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08

Study Completion Date2027-09-10

Study Record Updates

Study Start Date2024-10-08

Study Completion Date2027-09-10

Terms related to this study

Keywords Provided by Researchers

medical device
skin cancer detection
elastic scattering spectroscopy

Additional Relevant MeSH Terms

Melanoma, Skin