Investigating the Clinical Utility of the MDS (OMS002_UK)

Orlucent

Status: Completed

Conditions: Moles; Melanoma; Skin Lesion

Treatments: Diagnostic Test: Melanoma Detection System -MDS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03109327

OMS002_UK

Details and patient eligibility

About

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

Full description

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 2 patient groups

Urgent Excision

Description:

Subjects with moles suspicious of melanoma and are scheduled for an urgent excision.

Treatment:

Diagnostic Test: Melanoma Detection System -MDS

Non-urgent Excision

Description:

Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision.

Treatment:

Diagnostic Test: Melanoma Detection System -MDS