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Pigment; LesionNCT05692544

Image Data Collection of Tanned Skin During Phototherapy Treatment Using a Multi-spectral Camera

An observational study of Pigment; Lesion and Lesion; Vascular, run by Lumenis Be Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, observational, single-center, image collection study. Any patient who arrived at the phototherapy clinic for the first time, regardless of this study, and is prescribed a total of 30 treatments can be included, regardless of skin or medical condition. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pigment; Lesion, Lesion; Vascular
What is being tested?
Phototherapy treatment
Type of treatment
Surgery or procedure
How many people
10 participants
Where
No sites listed yet
Study dates
Nov 2023to Feb 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Up to 10 subjects should be included in this study.

Who may be able to join

  • Any patient, male or female 18 years or older.
  • Patient is scheduled for 30 treatments or more of phototherapy
  • Subject is capable and willing to sign an informed consent
  • Subject is willing to comply with study schedule
  • Subject has areas of skin that do not consist any marked lesions, hairs or skin conditions and can be captured in the study

Who cannot join

  • Subjects incapable of providing an informed consent

About this study

This is a prospective, observational, single-center, image collection study. Any patient who arrived at the phototherapy clinic for the first time, regardless of this study, and is prescribed a total of 30 treatments can be included, regardless of skin or medical condition.

After consenting subjects at least 5 close-up images will be taken from the specified anatomical areas, at different angles, using the SMART camera. Additional reference images of skin that is not exposed to the phototherapy treatment will be taken with the SMART Camera. Global image of the skin using a regular high-resolution camera is optional. The images will be collected on baseline visit, at least every 3 phototherapy treatments (approximately once a week), and at the last phototherapy treatment visit. i.e., in total of at least 11 phototherapy treatment visits. Follow-up images will be taken at 1-week and 2 weeks following the last phototherapy treatment.

Images shall be taken from any anatomical area that does not consist of any marked lesions or skin conditions. All images will be non-identifying.

Read the detailed description

The SMART camera is advanced proprietary multi-spectral system camera, developed for research purposes. The SMART camera system is based on commercially available components and consists of 3 modules:

  1. Camera Handpiece- Spectral module with a monochromatic camera, optics, and an array of LEDs at 7 different wavelengths.
  2. Control Unit - an electronic box that powers and controls the camera. It includes electronics and a miniature computer.
  3. Touch screen monitor - With user interface to operate the system When taking a photo, a series of cross-polarized monochromatic images are taken, each at different illumination color (wavelength). In total, seven images are taken with blue (450nm), teal (490nm), lime (570nm), orange (590nm), red (660nm), IR-1 (730nm), IR-2 (860nm). The total acquisition time for the seven images is 0.1sec. The images are stored in a dedicated directory on a removable hard disk in the control unit in correlation to patient ID entered through the user interface on the laptop. The number of images that can be taken is unlimited.

The camera passed the following safety tests by certified lab:

  1. Check-up Safety Testing - IEC-60601-1 tests for investigational device by external laboratories according to IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards
  2. LED Hazard Evaluation UV, Visible \& NIR Test, according to IEC62471 by an external certified laboratory
Being tested
Phototherapy treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phototherapy treatmentProcedure or surgery

    only patients was proscribe to phototherapy treatment can participate in the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Image data

    Images will be collected through the study

    Measured: 4-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study startNov 2023 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692544
Sponsor's protocol ID
LUM-ABU-SMRT-22-03
Status last verified
Apr 2023
First submitted
11 Jan 2023
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pigment; Lesion and Lesion; Vascular, run by Lumenis Be Ltd..

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 1 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Image data (time frame: 4-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692544.

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 6 Oct 2023.

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