Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01333553
First received: August 3, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The researcher at the Beckman Laser Institute develop non-invasive imaging modalities for assessment of port wine stain (PWS) during laser therapy treatment. The imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.


Condition Intervention
PORT WINE STAIN
Device: Laser Speckle Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring the Response of PWS Birthmarks to Laser Therapy With Wide-field

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Method to monitor the response of laser treatment of port wien stain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The proposed research is significant, because our image-guided surgery approach will show color images which will be used to adjust energy of the laser treatment, reducing ultimately the number of treatment sessions and the associated medical care burden.


Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Laser Speckle Imaging
Laser Speckle Imaging
Device: Laser Speckle Imaging
Assessment of port wine stain birthmarks to laser therapy

Detailed Description:

The degree of photocoagulation caused by laser therapy will be assessed with LSI and SFDI.The imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a CCD camera.The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive 3D visualization of sub-surface structures.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

  • All minors, birth to 18 years of age or older with PWS birthmark
  • Ability to understand and carry out subject instructions
  • Sign photograph release form

Exclusion Criteria:

  • Inability to understand and/or carry out instructions
  • Pregnant women
  • Do not sign photograph release form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333553

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Bernard Choi, PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01333553     History of Changes
Other Study ID Numbers: LAMMP-30139; HS#2010-7376
Study First Received: August 3, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
PWS

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014