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| ID | Type | Description | Link |
|---|---|---|---|
| UAMS Sponsored |
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PI moved out of state.
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| Name | Class |
|---|---|
| Arkansas Children's Hospital Research Institute | OTHER |
| Children's University Medical Group | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermoVision A20M Infrared Camera | Device | FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff. | ||
| ScleroPLUS | Device | 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. | ||
| 3D Digital Camera | Device | 3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gal Shafirstein, PhD | UAMS, ACH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Therapy | Total number of participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Overall Study Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation. | Posted | Three treatments up to one year, whichever is first |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | Overall Study Group |
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PI relocated and protocol was terminated, and no subject returned for treatment under protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gal Shafirstein | University of Arkansas for Medical Sciences/Arkansas Children's Hospital | 501-364-7546 | jboswell@uams.edu |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |