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

October 30, 2005 updated by: Rambam Health Care Campus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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%

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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%

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Lumenis Be Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Registration Dates

First Submitted

October 30, 2005

First Submitted That Met QC Criteria

October 30, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2005

Last Update Submitted That Met QC Criteria

October 30, 2005

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • danaCTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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