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Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585338
First Posted: January 3, 2008
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose

Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.

It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.

The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.


Condition Intervention Phase
Vascular Lesion Device: Tandem 532/1064 nm Laser Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Laser treatment [ Time Frame: 6 months ]
    Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser


Enrollment: 1
Study Start Date: December 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tandem 532/1064 nm Laser
Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser
Device: Tandem 532/1064 nm Laser
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Other Name: Treatment of Vascular Lesions

Detailed Description:

The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment.

The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult age 18 years and older
  • Diagnosis of vascular lesion

Exclusion Criteria:

  • Age <18
  • Pregnancy
  • History of cutaneous photosensitivity
  • Any therapy to the proposed treatment sites within the previous two months
  • Current participation in any other investigational drug or device evaluation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585338


Locations
United States, California
Beckman Laser Institute Medical and Surgical Clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Study Director: John S Nelson, M.D, PhD Beckman Laser Institute University of California Irvine
Principal Investigator: Wangcun Jia, PhD Beckman Laser Institute University of California Irvine
Principal Investigator: Kristen Kelly, M.D Beckman Laser Institute University of California Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Wangcun Jia, PhD., Research Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585338     History of Changes
Other Study ID Numbers: NIH-LAMMP-ASLMS-2003-3086
First Submitted: December 18, 2007
First Posted: January 3, 2008
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
facial telangiectasia,
leg vein telangiectasia
Port Wine Stain birthmarks