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Personalized Interactive Laser Therapy of Port Wine Stain

This study has been terminated.
(PI moved out of state.)
Sponsor:
Collaborators:
Arkansas Children's Hospital Research Institute
Children's University Medical Group
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00782483
First received: October 29, 2008
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Port Wine Stain
Interventions: Device: ThermoVision A20M Infrared Camera
Device: ScleroPLUS
Device: 3D Digital Camera

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Laser Therapy Total number of participants

Participant Flow:   Overall Study
    Laser Therapy  
STARTED     6 [1]
COMPLETED     0  
NOT COMPLETED     6  
Early Termination of Protocol - PI Reloc                 6  
[1] 6 subjects enrolled beginning on 04/27/2009 with last enrollment on 04/13/2010.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Overall Study Group

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     5  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures

1.  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.   [ Time Frame: Three treatments up to one year, whichever is first ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
PI relocated and protocol was terminated, and no subject returned for treatment under protocol.


  More Information
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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
e-mail: jboswell@uams.edu


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00782483     History of Changes
Other Study ID Numbers: 104344, UAMS Sponsored
Study First Received: October 29, 2008
Results First Received: January 6, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board