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

Primary Purpose

Telangiectases, Port Wine Stain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IPL Quantum Product manufactured by Luminis Ltd.
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telangiectases focused on measuring Vascular lesions, Intense pulse light, phototermolysis, wavelength, filters, non coherent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Plastic surgery dept., Rambam medical center

Outcomes

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%

Secondary Outcome Measures

Full Information

First Posted
October 30, 2005
Last Updated
October 30, 2005
Sponsor
Rambam Health Care Campus
Collaborators
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00247299
Brief Title
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
Official Title
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus
Collaborators
Lumenis Be Ltd.

4. Oversight

5. Study Description

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: evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications. Reconfirm the parameter settings for each of the aforementioned clinical applications. 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: No clearance 0-25% 25-50% 50-75% 75-100%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectases, Port Wine Stain
Keywords
Vascular lesions, Intense pulse light, phototermolysis, wavelength, filters, non coherent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
IPL Quantum Product manufactured by Luminis Ltd.
Primary Outcome Measure Information:
Title
Every subject will be treated 5 treatments , with 5+1 weeks interval.
Title
clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
Title
1. No clearance
Title
2. 0-25%
Title
3. 25-50%
Title
4. 50-75%
Title
5. 75-100%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehuda Ullmann, MD
Organizational Affiliation
Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Plastic surgery dept., Rambam medical center
City
Haifa
ZIP/Postal Code
9602
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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