Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03464604
Eligibility Criteria:
Inclusion Criteria:
* New referral from a general practitioner to a dermatologist
* Males and females, over the age of 18 are eligible to participate
* Written informed consent from the patient
* Lesion or mole is new, changing color, growing rapidly or has a change in sensation
* Willing to have the lesion excised if necessary per standard of care
* Ability to complete the imaging procedure and willing to complete a basic history
* Pigmented lesion considered low, moderate or high risk for melanoma by a general practitioner
Exclusion Criteria
* Lesions which are not amenable
* Participant unable to read, understand or sign consent
* Participant under active care by a dermatologist
* Lesion \<2 mm or \>15mm in diameter
* Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions
* Lesion on hair covered areas (e.g. scalp, beard, mustache) where hair cannot be removed
* Lesions located on genitalia not accessible to equipment
* Lesions located in an area that has previously biopsied or subjected to any kind of surgical or ablative procedure
* Lesion with foreign matter, e.g. tattoo or splinter
* Lesion and/or reference located on acute sunburn
* Skin surface not measurable, e.g. lesion on a stalk
* Skin surface not accessible, e.g. inside ears, ears, under nails
* Skin not intact (measurement area), e.g. bleeding or with clinically noticeable ulceration
* Lesions located within 1cm of the eye
* Lesions light in pigment or thick and nodular
* Participants not willing to have the lesion excised
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03464604
Study Brief:
Protocol Section:
NCT03464604