Vascular LesionNCT05674149
Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development
A study testing camera in people with Vascular Lesion and Pigmented Lesions, run by Lumenis Be Ltd. at 1 site in Israel.
Trial summary
This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Lesion, Pigmented Lesions
- What is being tested?
- camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jun 2023to Mar 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following inclusion criteria to be entered into the study:
- Any patient, male or female of at least 18 years old, who is willing to sign an informed consent form and present at least one of the following conditions:
- Photoaging (type I - III per Glogau classification)- mixed conditions
- Epidermal pigmentation / Lentigines (age spots, sun spots)
- Facial rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)
- Facial telangiectasia
Show all 9Show fewer
- Poikiloderma
- Seborrheic keratosis
- Melasma (Chloasma)
Who cannot join
- Any of the following will exclude the subject from the study:
- The study is intended to gather image data so, any patient can be included in the study, and no exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
Michael Ziv, MD contact
Israel1 site, 1 recruiting
- Recruiting
Ha'Emek Medical Center
Afula, 20692
Rula Masoud, rula.masoud@lumenis.com
About this study
This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.
Read the detailed description
This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.
The specified lesions can be located on any area of the face or body. For consenting subjects at least 5 close-up images of at least one lesion and one reference image (e.g., subject's skin without any lesion) will be obtained using the Multi-spectral SMART camera. An additional reference image of the lesion area will be taken with a regular camera. Optional images may be taken using a dermatoscop
- Conditions
- Vascular Lesion, Pigmented Lesions
- Being tested
- camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cameraDevice
photographs using multi-spectral camera
| Study group | Role | What they receive |
|---|---|---|
| Multi-Spectral Camera | Other | Multi-Spectral Camera will be used in order to capture images of different skin conditions Receives: Device: camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Images collection
Images of different skin condition will be collected using multispectral camera
Measured: through study completion, up to 4 months
Secondary outcomes (1)
Images data collection
for each collected image using multispectral camera, skin an lesion attributes will be evaluated by the investigator. the following attribute will be collected: skin type, lesion type, lesion intensity
Measured: through study completion, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start21 Jun 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emek Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674149
- Sponsor's protocol ID
- LUM-ABU-SMRT-22-04
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development
- ClinicalTrials.gov ID
- NCT05674149
- Acronym / sponsor ID
- LUM-ABU-SMRT-22-04
- Conditions
- Vascular Lesion, Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Emek Medical Center
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Jan 2023 (actual)
- 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.
This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.
Detailed description
This is an observational, single-center, open-label photography evaluation. Any patient that arrives for consultation or treatment at the clinic, presenting the required lesions detailed in the protocol can be included.
The specified lesions can be located on any area of the face or body. For consenting subjects at least 5 close-up images of at least one lesion and one reference image (e.g., subject's skin without any lesion) will be obtained using the Multi-spectral SMART camera. An additional reference image of the lesion area will be taken with a regular camera. Optional images may be taken using a dermatoscop
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Spectral Camera | Other | Device: cameraMulti-Spectral Camera will be used in order to capture images of different skin conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Any patient, male or female of at least 18 years old, who is willing to sign an informed consent form and present at least one of the following conditions:
- Photoaging (type I - III per Glogau classification)- mixed conditions
- Epidermal pigmentation / Lentigines (age spots, sun spots)
- Facial rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)
- Facial telangiectasia
Key exclusion criteria (2 listed)
- The study is intended to gather image data so, any patient can be included in the study, and no exclusion criteria apply.
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 |
|---|---|---|
| cameraphotographs using multi-spectral camera | Device | Multi-Spectral Camera |
Primary outcome
Images collection
Time frame: through study completion, up to 4 months
Images of different skin condition will be collected using multispectral camera
1 secondary outcome
Images data collection
Time frame: through study completion, up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Michael Ziv, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing camera in people with Vascular Lesion and Pigmented Lesions, run by Lumenis Be Ltd. 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rula Masoud, PhD (0503018155, rula.masoud@lumenis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Images collection (time frame: through study completion, up to 4 months). 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 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.