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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Rambam Health Care Campus
Lumenis Ltd.
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00247299
  Purpose

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.

Condition Intervention
Telangiectases
Port Wine Stain
Device: IPL Quantum Product manufactured by Luminis Ltd.

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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%

Estimated Enrollment:   30
Study Start Date:   May 2005

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%
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247299

Locations
Israel
Plastic surgery dept., Rambam medical center    
      Haifa, Israel, 9602

Sponsors and Collaborators
Rambam Health Care Campus
Lumenis Ltd.

Investigators
Principal Investigator:     Yehuda Ullmann, MD     Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel    
  More Information

Study ID Numbers:   danaCTIL, danaCTIL
First Received:   October 30, 2005
Last Updated:   October 30, 2005
ClinicalTrials.gov Identifier:   NCT00247299
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Vascular lesions  
Intense pulse light  
phototermolysis  
wavelength
filters
non coherent

Study placed in the following topic categories:
Skin Diseases
Nevi flammei, familial multiple
Port-Wine Stain
Telangiectasis
Skin Abnormalities
Vascular Diseases
Congenital Abnormalities

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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