NCT00585338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

December 18, 2007

Last Update Submit

October 19, 2022

Conditions

Vascular Lesion

Keywords

facial telangiectasia,leg vein telangiectasiaPort Wine Stain birthmarks

Outcome Measures

Primary Outcomes (1)

  • Laser treatment

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

    6 months

Study Arms (1)

Tandem 532/1064 nm Laser

EXPERIMENTAL

Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser

Device: Tandem 532/1064 nm Laser

Interventions

Tandem 532/1064 nm LaserDEVICE

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

Also known as: Treatment of Vascular Lesions
Tandem 532/1064 nm Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical and Surgical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • John S Nelson, M.D, PhD

    Beckman Laser Institute University of California Irvine

    STUDY DIRECTOR

  • Wangcun Jia, PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

  • Kristen Kelly, M.D

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wangcun Jia, PhD., Research Scientist

Study Record Dates

First Submitted

December 18, 2007

First Posted

January 3, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)