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

NCT00247299 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2005-11-01

No results posted yet for this study

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.

Conditions

  • Telangiectases
  • Port Wine Stain

Interventions

DEVICE

IPL Quantum Product manufactured by Luminis Ltd.

Sponsors & Collaborators

  • Lumenis Be Ltd.

    collaborator INDUSTRY

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Yehuda Ullmann, MD · Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00247299 on ClinicalTrials.gov