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

NCT ID: NCT00247299

Last Updated: 2005-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31

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:

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

Keywords

Vascular lesions; Intense pulse light; phototermolysis; wavelength; filters; non coherent

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

IPL Quantum Product manufactured by Luminis Ltd.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Principal Investigators

Yehuda Ullmann, MD

Role: PRINCIPAL_INVESTIGATOR

Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel

Locations

Plastic surgery dept., Rambam medical center

Haifa, , Israel

Countries

Israel

Other Identifiers

danaCTIL

Identifier Type: -

Identifier Source: secondary_id

danaCTIL

Identifier Type: -

Identifier Source: org_study_id