Clinical Trials Directory

Trials / Completed

CompletedNCT00842296

ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
326 (actual)
Sponsor
Medtronic Endovascular · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICERF ablation (ClosureFAST)Segmental RF Ablation with the CLF catheter

Timeline

Start date
2006-04-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2009-02-12
Last updated
2018-03-12
Results posted
2017-12-11

Source: ClinicalTrials.gov record NCT00842296. Inclusion in this directory is not an endorsement.