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| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2005 | ||||
| Last Updated Date | October 30, 2005 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform | ||||
| Official Title ICMJE | Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform | ||||
| Brief 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:
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| 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:
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: IPL Quantum Product manufactured by Luminis Ltd. | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00247299 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | danaCTIL, danaCTIL | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Lumenis Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | October 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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