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

Vascular Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585338
• Other study ID #: 20033086
• Status: Completed
• Phase: Phase 1
• Start date: December 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Lesion

Intervention

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

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical and Surgical Clinic	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laser treatment	Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser	6 months