Skin Lesions
Conditions
Keywords
Melanoma, Skin Cancer
Brief summary
The use of MDS to access the presence of melanoma in the skin.
Detailed description
A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.
Interventions
None listed
Sponsors
Orlucent, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 97 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy. * The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS. * Male and female ≥ 21 years old. * Subject is capable of giving written informed consent. * Primary excision.
Exclusion criteria
* The lesion is less than 1 cm from the eyes. * The lesion is on the palms of hands or soles of the feet. * Mucosal lesion. * Pregnant females. * Low study procedure compliance. * Patients who are mentally or physically unable to comply with all aspects of the study. * Undergoing chemotherapy. * Minor or legally incompetent and not able to sign the consent form. * Patient previously tested by MDS and was diagnosed with melanoma during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate the performance of MDS | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination. | 28 days |
Other
| Measure | Time frame |
|---|---|
| To further establish the safety of the MDS. | 28 days |
Countries
Israel
Outcome results
None listed