Personalized Interactive Laser Therapy of Port Wine Stain

Study Overview
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Brief Summary
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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.

Official Title
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Personalized Interactive Laser Therapy of Port Wine Stain - Study 2

Conditions
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Port Wine Stain

Intervention / Treatment
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* Device: ThermoVision A20M Infrared Camera
* Device: ScleroPLUS
* Device: 3D Digital Camera


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ThermoVision A20M Infrared Camera|FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.|
|Device: ScleroPLUS|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.|
|Device: 3D Digital Camera|3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three treatments up to one year, whichever is first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, Port Wine Stain, PWS