Investigating the Clinical Utility of the MDS

Orlucent, Inc250 enrolled

Overview

The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Skin Lesion Melanoma Moles

Interventions

Melanoma Detection System -MDSDIAGNOSTIC_TEST

Imaging of lesion using the MDS test.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Lesion has one or more of the ABCDE features and is recommended for excision. 2. Lesion has at least 1 cm of skin around it that is accessible to the MDS. 3. Patient is at least 18 years old. 4. Patient is capable of giving written informed consent. 5. Lesion is scheduled for primary excision. Exclusion Criteria: 1. Lesion is less than one centimetre from the eyes. 2. Lesion is on the palms of the hands or soles of the feet. 3. Lesion is mucosal. 4. Lesion is ulcerated. 5. Patient is pregnant. 6. Low patient study procedure compliance. 7. Patient who is mentally or physically unable to comply with all aspects of the study. 8. Patient is undergoing chemotherapy. 9. Patient has known sensitivity to fluorescent dyes. 10. Ink marking on or adjacent to lesion. 11. Lesions larger than 20mm or too large to allow imaging.

Locations (1)

NHS Lanarkshire, Monklands Hospital

Airdrie, United Kingdom

Outcomes

Primary Outcomes

Utility of the MDS in determining urgent or non-urgent excision of moles.

The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation.

Time frame: 1 day

Secondary Outcomes

Does the MDS have an additive value to clinical evaluation of moles.

Does the MDS system provide superior results when compared to clinical evaluation.

Time frame: 1 day

Data from ClinicalTrials.gov

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