ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
This trial is active, not recruiting.
|Conditions||great saphenous disease, venous reflux|
|Treatment||rf ablation (closurefast)|
|Sponsor||VNUS Medical Technologies, A Covidien Company|
|Start date||April 2006|
|End date||December 2012|
|Trial size||396 participants|
|Trial identifier||NCT00842296, CLF-05-03|
The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Single Arm with CLF Catheter
Vein occlusion rate
time frame: 5yr
Status of clinical signs and symptoms of lower limb venous disease
time frame: 5 yr
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Age between 18 and 80 years of age at the time of enrollment - Symptomatic lower limb venous disease involving the GSV Exclusion Criteria: - Thrombosis in the vein segment to be treated - Known or suspected pregnancy or actively breast feeding at time of treatment
|Official title||ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element|
|Description||The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.|
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