An interventional study of camera in Vascular Lesion and Pigmented Lesions, sponsored by Lumenis Be Ltd.. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Other
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.
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
Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 form and present at least one of the following conditions:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multi-Spectral Camera will be used in order to capture images of different skin conditions
Device: camera
photographs using multi-spectral camera
Images collection
Images of different skin condition will be collected using multispectral camera
Time frame: through study completion, up to 4 months
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
Time frame: through study completion, up to 4 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Mar 2024, 9 months after the start.
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