NCT00247299

Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Background: 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 wavelegths longer than these of the filters are transmitted. Material and Methods: The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA) incorporate the non coherent pulsed light head. Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with the following filters :515,50,or 590. Following every treatment the subjects will be asked how much pain was felt , using a score of 1-5. Photographs will be taken before each treatments . Every subject will be treated 5 treatments , with 5+1 weeks interval. clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale: 1. No clearance 2. 0-25% 3. 25-50% 4. 50-75% 5. 75-100%

Conditions

• Telangiectases
• Port Wine Stain

Interventions

Type	Name	Description
DEVICE	IPL Quantum Product manufactured by Luminis Ltd.

Timeline

• Start date: 2005-05-01
• First posted: 2005-11-01
• Last updated: 2005-11-01

Locations

1 site across 1 country: Israel