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

October 5, 2023 updated by: Lumenis Be Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Up to 10 subjects should be included in this study.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Subjects incapable of providing an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Image data
Time Frame: 4-months
Images will be collected through the study
4-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lumenis Be Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUM-ABU-SMRT-22-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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