Back to resultsPersonalized Interactive Laser Therapy of Port Wine Stain
Primary Purpose
Port Wine Stain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ThermoVision A20M Infrared Camera
ScleroPLUS
3D Digital Camera
Sponsored by
About this trial
This is an interventional treatment trial for Port Wine Stain focused on measuring Diagnosis, Port Wine Stain, PWS
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with a PWS
- At least one visible PWS measuring greater than or equal to 15 mm in diameter.
- Information provided regarding alternative treatment methods, includig no treatment.
- Reading, understanding, and signing of an informed consent document.
- Children age 7 years or older has read, understood, and signed an assent document.
- Agreement to participate in the study.
- Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
- Zubrod performance status of 0 or 1 at screening.
Exclusion Criteria:
- Inability or unwillingness of subject to participate in the study.
- Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
- Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
Sites / Locations
- Arkansas Children's Hospital
Outcomes
Primary Outcome Measures
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Secondary Outcome Measures
Full Information
NCT ID
NCT00782483
First Posted
October 29, 2008
Last Updated
June 19, 2014
Sponsor
University of Arkansas
Collaborators
Arkansas Children's Hospital Research Institute, Children's University Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT00782483
Brief Title
Personalized Interactive Laser Therapy of Port Wine Stain
Official Title
Personalized Interactive Laser Therapy of Port Wine Stain - Study 2
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
PI moved out of state.
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Arkansas Children's Hospital Research Institute, Children's University Medical Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain
Keywords
Diagnosis, Port Wine Stain, PWS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
ThermoVision A20M Infrared Camera
Intervention Description
FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
Intervention Type
Device
Intervention Name(s)
ScleroPLUS
Intervention Description
Sclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled.
Intervention Type
Device
Intervention Name(s)
3D Digital Camera
Intervention Description
3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.
Primary Outcome Measure Information:
Title
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
Description
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Time Frame
Three treatments up to one year, whichever is first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with a PWS
At least one visible PWS measuring greater than or equal to 15 mm in diameter.
Information provided regarding alternative treatment methods, includig no treatment.
Reading, understanding, and signing of an informed consent document.
Children age 7 years or older has read, understood, and signed an assent document.
Agreement to participate in the study.
Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
Zubrod performance status of 0 or 1 at screening.
Exclusion Criteria:
Inability or unwillingness of subject to participate in the study.
Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gal Shafirstein, PhD
Organizational Affiliation
UAMS, ACH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Personalized Interactive Laser Therapy of Port Wine Stain
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