RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study (TRIPLE)
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|ClinicalTrials.gov Identifier: NCT01079598|
Recruitment Status : Terminated (Low enrollment)
First Posted : March 3, 2010
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Venous Insufficiency||Device: RF Ablation (ClosureRFS Stylet)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
RF ablation with ClosureRFS Stylet
Device: RF Ablation (ClosureRFS Stylet)
Bipolar energy radiofrequency ablation with RFS stylet
- Quality of Life and Clinical Assessments Compared to Pretreatment Baseline. [ Time Frame: 6 months ]QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.
- Cessation of Flow Through the Perforator Vein [ Time Frame: 6 months ]Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.
- CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology) [ Time Frame: 6 months ]CEAP Classification at Month 6 will be reported.
- Cessation of Flow Reflux Through the Perforator Vein [ Time Frame: 6 months ]Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079598
|United States, Alabama|
|Varicosity Vein Center|
|Birmingham, Alabama, United States, 35213|
|United States, Georgia|
|Vein Care Pavilion of the South|
|Evans, Georgia, United States, 30809|
|United States, Michigan|
|Allegiance Vascular Health|
|Jackson, Michigan, United States, 49201|
|Study Director:||Melissa Hasenbank, PhD||Medtronic|