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:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01333553
First received: August 3, 2010
Last updated: June 6, 2015
Last verified: June 2015
  Purpose

The researcher develop non-invasive imaging modalities for assessment of port wine stain during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.


Condition Intervention
PORT WINE STAIN
Device: Image-guided remove Port Wine Stain

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

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

Primary Outcome Measures:
  • Image-guided surgery remove Port Wine Stain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Image-guided surgery remove Port Wine Stain


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
Image-guided remove Port Wine Stain
Image-guided surgery remove Port Wine Stain
Device: Image-guided remove Port Wine Stain
Image-guided surgery remove Port Wine Stain

Detailed Description:

The researcher can use 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 camera.The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive visualization of sub-surface structures of Port Wine Stain.

  Eligibility

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

Study population will be selected from an outpatient population with Port Wine Stain birthmark at Beckman Laser Institute and Medical Clinic, University of California, Irvine. Patients with Port Wine Stain birthmark will be candidates for participation.

Criteria

Inclusion Criteria:

  • All minors, birth to 18 years of age or older with Port Wine Stain 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
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Bernard Choi, PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Bernard Choi, Ph.D., Assistant Professor Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01333553     History of Changes
Other Study ID Numbers: NIH/LAMMP-2010-7376
Study First Received: August 3, 2010
Last Updated: June 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
birthmark

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

ClinicalTrials.gov processed this record on July 30, 2015