Investigating the Clinical Utility of the MDS

NCT ID: NCT03109327

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-10-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Skin Lesion Melanoma Moles

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Urgent Excision

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

Melanoma Detection System -MDS

Intervention Type DIAGNOSTIC_TEST

Imaging of lesion using the MDS test.

Non-urgent Excision

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

Melanoma Detection System -MDS

Intervention Type DIAGNOSTIC_TEST

Imaging of lesion using the MDS test.

Interventions

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Melanoma Detection System -MDS

Imaging of lesion using the MDS test.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MDS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lanarkshire

OTHER_GOV

Sponsor Role collaborator

NHS Tayside

OTHER_GOV

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

University Hospitals, Leicester

OTHER

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role collaborator

Orlucent, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NHS Lanarkshire, Monklands Hospital

Airdrie, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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OMS002_UK

Identifier Type: -

Identifier Source: org_study_id