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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02193581 |
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Date of registration:
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08/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
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Scientific title:
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Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System) |
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Date of first enrolment:
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August 30, 2017 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02193581 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Israel
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Contacts
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Name:
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Sharon Merims, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Organization |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals with skin lesion with one or more of the ABCDE features and recommended
for a skin biopsy.
- The lesion is accessible to the imaging device, with at least 1 cm of skin around the
lesion that is accessible to the MDS.
- Male and female = 21 years old.
- Subject is capable of giving written informed consent.
- Primary excision.
Exclusion Criteria:
- The lesion is less than 1 cm from the eyes.
- The lesion is on the palms of hands or soles of the feet.
- Mucosal lesion.
- Pregnant females.
- Low study procedure compliance.
- Patients who are mentally or physically unable to comply with all aspects of the
study.
- Undergoing chemotherapy.
- Minor or legally incompetent and not able to sign the consent form.
- Patient previously tested by MDS and was diagnosed with melanoma during the study.
- Sensitivity to fluorescein
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Skin Lesion
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Intervention(s)
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Device: MDS
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Primary Outcome(s)
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The MDS produces a score between 1 to 10.
[Time Frame: 28 days]
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Secondary ID(s)
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OMS 001_HMO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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