NCT01333553

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

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

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

8 years

First QC Date

August 3, 2010

Last Update Submit

October 28, 2022

Conditions

PORT WINE STAIN

Keywords

birthmark

Outcome Measures

Primary Outcomes (1)

  • Image-guided surgery remove Port Wine Stain

    Image-guided surgery remove Port Wine Stain

    24 hours

Study Arms (1)

Image-guided remove Port Wine Stain

Image-guided surgery remove Port Wine Stain

Device: Image-guided remove Port Wine Stain

Interventions

Image-guided remove Port Wine StainDEVICE

Image-guided surgery remove Port Wine Stain

Image-guided remove Port Wine Stain

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to understand and/or carry out instructions
  • Pregnant women
  • Do not sign photograph release form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bernard Choi, PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bernard Choi, Ph.D., Assistant Professor Biomedical Engineering

Study Record Dates

First Submitted

August 3, 2010

First Posted

April 12, 2011

Study Start

April 1, 2010

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)