Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development

Sponsor
Lumenis Be Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05674149
Collaborator
Emek Medical Center (Other)
210
1
3.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: camera
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Image Data Collection Using a Multi-spectral Camera for Computer Vision Algorithms Research and Development
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Multi-Spectral Camera

Multi-Spectral Camera will be used in order to capture images of different skin conditions

Device: camera
photographs using multi-spectral camera

Outcome Measures

Primary Outcome Measures

  1. Images collection [through study completion, up to 4 months]

    Images of different skin condition will be collected using multispectral camera

Secondary Outcome Measures

  1. Images data collection [through study completion, up to 4 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
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:

  1. Photoaging (type I - III per Glogau classification)- mixed conditions

  2. Epidermal pigmentation / Lentigines (age spots, sun spots)

  3. Facial rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)

  4. Facial telangiectasia

  5. Poikiloderma

  6. Seborrheic keratosis

  7. Melasma (Chloasma)

Exclusion Criteria:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lumenis Be Ltd.
  • Emek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lumenis Be Ltd.
ClinicalTrials.gov Identifier:
NCT05674149
Other Study ID Numbers:
  • LUM-ABU-SMRT-22-04
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 6, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 6, 2023