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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of California, Irvine
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: February 5, 2016
Last verified: February 2016
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   Child, Adult, Senior
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

Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute Medical clinic Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Sub-Investigator: Stuart Nelson, MD,PhD         
Sub-Investigator: Kristen Kelly, MD         
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

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: February 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
birthmark

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016