An interventional study of ThermoVision A20M Infrared Camera and ScleroPLUS in Port Wine Stain, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2014-07-21.
Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment
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.
83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.
This study's enrollment of 6 is below the median of 33 across 56 interventional studies indexed under Hemangioma, Capillary.
Browse Hemangioma, Capillary studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
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.
3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.
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.
Time frame: Three treatments up to one year, whichever is first
| Milestone | Laser Therapy |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
| Withdrew: Early termination of protocol - pi reloc | 6 |
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Overall |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 2 |
| Male | 4 |
| Region of Enrollment(participants) | Overall |
|---|---|
| United States | 6 |
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University of Arkansas