Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform (NCT00247299) | Clinical Trial Compass
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Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
Israel30 participantsStarted 2005-05
Plain-language summary
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelengths longer than these of the filters are transmitted.
objectives:
1. evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.
2. Reconfirm the parameter settings for each of the aforementioned clinical applications.
3. Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy Subjects, presenting with at least one of the clinical indications mentioned above
* Willing and being able to comply with all visit and evaluation requirements
* Willing and being able to provide signed Informed Consent
Exclusion Criteria:
* A history of keloid scar formation or poor wound healing
* Wounded or tanned in area to be treated
* Pregnant or intending to become pregnant during the evaluation period
* Subjects with a bleeding disorder or who take anticoagulation medications
* Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestive heart failure
* Significant concurrent skin conditions affecting area to be treated
* Having a history of skin cancer or any other cancer in the area to be treated
* History of immunosuppressive disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Every subject will be treated 5 treatments , with 5+1 weeks interval.
2
clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale: