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

August 3, 2010
June 6, 2015
April 2010
June 2017   (final data collection date for primary outcome measure)
Image-guided surgery remove Port Wine Stain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Image-guided surgery remove Port Wine Stain
Method to guide number of laser treatment during treatment session and futher treatment. [ 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.
Complete list of historical versions of study NCT01333553 on ClinicalTrials.gov Archive Site
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Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies
Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

PORT WINE STAIN
Device: Image-guided remove Port Wine Stain
Image-guided surgery remove Port Wine Stain
Image-guided remove Port Wine Stain
Image-guided surgery remove Port Wine Stain
Intervention: Device: Image-guided remove Port Wine Stain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333553
NIH/LAMMP-2010-7376
No
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Bernard Choi, PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP