Study Results
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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COMPLETED
250 participants
OBSERVATIONAL
2018-04-01
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
Imaging of lesion using the MDS test.
Interventions
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Melanoma Detection System -MDS
Imaging of lesion using the MDS test.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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NHS Lanarkshire
OTHER_GOV
NHS Tayside
OTHER_GOV
NHS Greater Glasgow and Clyde
OTHER
University Hospitals, Leicester
OTHER
University of Dundee
OTHER
Orlucent, Inc
INDUSTRY
Responsible Party
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Locations
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NHS Lanarkshire, Monklands Hospital
Airdrie, , United Kingdom
Countries
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Other Identifiers
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OMS002_UK
Identifier Type: -
Identifier Source: org_study_id