Skin LesionNCT02193581
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
An observational study of Skin Lesion, run by Orlucent, Inc at 1 site in Israel.
Trial summary
The use of MDS to access the presence of melanoma in the skin. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Skin Lesion
- What is being tested?
- MDS
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Aug 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
The use of MDS to access the presence of melanoma in the skin.
Read the detailed 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.
- Conditions
- Skin Lesion
- Being tested
- MDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDSDevice
Patients with a suspicious lesion, referred for a biopsy is tested using MDS.
| Study group | Role | What they receive |
|---|---|---|
| Suspicious skin lesions. | Patients with a suspicious skin lesion referred for a biopsy are tested using MDS Receives: Device: MDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MDS produces a score between 1 to 10.
The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start30 Aug 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Sharon Merims, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193581
- Sponsor's protocol ID
- OMS 001_HMO
- Status last verified
- Feb 2018
- First submitted
- 8 Jul 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
- ClinicalTrials.gov ID
- NCT02193581
- Acronym / sponsor ID
- OMS 001_HMO
- Conditions
- Skin Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of MDS to access the presence of melanoma in the skin.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicious skin lesions. | – | Device: MDSPatients with a suspicious skin lesion referred for a biopsy are tested using MDS |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDSPatients with a suspicious lesion, referred for a biopsy is tested using MDS. | Device | Suspicious skin lesions. |
Primary outcome
The MDS produces a score between 1 to 10.
Time frame: 28 days
The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Merims, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesion, run by Orlucent, Inc at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MDS produces a score between 1 to 10. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.