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Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01197833
First received: September 8, 2010
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: February 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Great Saphenous Vein Incompetence
Visible Varicosities
Interventions: Drug: endovenous ablation+polidocanol injectable microfoam 0.125%
Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%
Drug: Endovenous ablation+polidocanol injectable foam 2.0%

  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
Endovenous Ablation, Vehicle Placebo Endovenous ablation followed by vehicle placebo
Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous ablation followed by polidocanol injectable foam, 0.5%
Endovenous Ablation, Polidocanol Injectable Foam 1.0% endovenous ablation followed by polidocanol injectable foam 1.0%

Participant Flow:   Overall Study
    Endovenous Ablation, Vehicle Placebo     Endovenous Ablation, Polidocanol Injectable Foam, 0.5%     Endovenous Ablation, Polidocanol Injectable Foam 1.0%  
STARTED     38     39     40  
COMPLETED     38     39     40  
NOT COMPLETED     0     0     0  



  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.
all treated patients

Reporting Groups
  Description
Endovenous Ablation, Vehicle Placebo Endovenous ablation followed by vehicle placebo
Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous ablation followed by polidocanol injectable foam, 0.5%
Endovenous Ablation, Polidocanol Injectable Foam 1.0% endovenous ablation followed by polidocanol injectable foam 1.0%
Total Total of all reporting groups

Baseline Measures
    Endovenous Ablation, Vehicle Placebo     Endovenous Ablation, Polidocanol Injectable Foam, 0.5%     Endovenous Ablation, Polidocanol Injectable Foam 1.0%     Total  
Number of Participants  
[units: participants]
  38     39     40     117  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 12.05     50.1  ± 11.60     51.8  ± 9.75     52.0  ± 11.18  
Gender  
[units: participants]
       
Female     26     29     26     81  
Male     12     10     14     36  
BMI  
[units: kg^m2]
Mean ± Standard Deviation
  29.3  ± 6.04     27.7  ± 4.58     28.1  ± 5.25     28.3  ± 5.32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)   [ Time Frame: IPR-V3 measured at baseline and then at 8 weeks ]

2.  Primary:   Absolute Change From Baseline in PA-V3 Score   [ Time Frame: PA-V3 measured at baseline and then at 8 weeks ]


  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
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  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: David Wright MB FRCS
Organization: BTG International Inc
phone: 610-278-1660
e-mail: david.wright@btgplc.com


No publications provided


Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01197833     History of Changes
Other Study ID Numbers: VAP.VV017
Study First Received: September 8, 2010
Results First Received: February 7, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration