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Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

O

Orlucent

Status

Completed

Conditions

Skin Lesion

Treatments

Device: MDS

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02193581
OMS 001_HMO

Details and patient eligibility

About

The use of MDS to access the presence of melanoma in the skin.

Full description

A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Suspicious skin lesions.
Description:
Patients with a suspicious skin lesion referred for a biopsy are tested using MDS
Treatment:
Device: MDS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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