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

NCT00247299 | Unknown

• 1 other identifier: danaCTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.
2. 2.Reconfirm the parameter settings for each of the aforementioned clinical applications.
3. 3.Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.

Conditions

Telangiectases; Port Wine Stain

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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%

Interventions

IPL Quantum Product manufactured by Luminis Ltd. DEVICE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Lumenis Be Ltd.: collaborator

Study Sites (1)

Plastic surgery dept., Rambam medical center

Haifa, 9602, Israel

Location

MeSH Terms

Conditions

Telangiectasis; Port-Wine Stain

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yehuda Ullmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2005
• First Posted: November 1, 2005
• Study Start: May 1, 2005
• Last Updated: November 1, 2005

Record last verified: 2005-10

Locations

IL (1)