Investigating the Clinical Utility of the MDS

Completed

• Conditions: Moles; Skin Lesion; Melanoma
• Interventions: Diagnostic Test: Melanoma Detection System -MDS

• Registration Number: NCT03109327
• Lead Sponsor: Orlucent, Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Study Start: 2018-04-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urgent Excision	Melanoma Detection System -MDS	Subjects with moles suspicious of melanoma and are scheduled for an urgent excision.
Non-urgent Excision	Melanoma Detection System -MDS	Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision.

Primary Outcome Measures

Name	Time	Method
Utility of the MDS in determining urgent or non-urgent excision of moles.	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Does the MDS have an additive value to clinical evaluation of moles.	1 day	Does the MDS system provide superior results when compared to clinical evaluation.

Trial Locations

Locations (1)

NHS Lanarkshire, Monklands Hospital; 🇬🇧 Airdrie, United Kingdom