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Trial record 17 of 32 for:    Stain | "Parkes Weber syndrome" OR "Vascular Malformations"

Personalized Interactive Laser Therapy of Port Wine Stain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00782483
Recruitment Status : Terminated (PI moved out of state.)
First Posted : October 31, 2008
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Collaborators:
Arkansas Children's Hospital Research Institute
Children's University Medical Group
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Port Wine Stain
Interventions Device: ThermoVision A20M Infrared Camera
Device: ScleroPLUS
Device: 3D Digital Camera
Enrollment 6

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser Therapy
Hide Arm/Group Description Total number of participants
Period Title: Overall Study
Started 6 [1]
Completed 0
Not Completed 6
Reason Not Completed
Early Termination of Protocol - PI Reloc             6
[1]
6 subjects enrolled beginning on 04/27/2009 with last enrollment on 04/13/2010.
Arm/Group Title Overall
Hide Arm/Group Description Overall Study Group
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
1
  16.7%
Between 18 and 65 years
5
  83.3%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Arm/Group Title Laser Therapy
Hide Arm/Group Description:
Total number of participants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall
Hide Arm/Group Description Overall Study Group
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall
Affected / at Risk (%)
Total   0/6 (0.00%) 
PI relocated and protocol was terminated, and no subject returned for treatment under protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Gal Shafirstein
Organization: University of Arkansas for Medical Sciences/Arkansas Children's Hospital
Phone: 501-364-7546
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00782483     History of Changes
Other Study ID Numbers: 104344
UAMS Sponsored
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: January 6, 2014
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014