ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by VNUS Medical Technologies, A Covidien Company.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
VNUS Medical Technologies, A Covidien Company
ClinicalTrials.gov Identifier:
NCT00842296
First received: February 10, 2009
Last updated: March 19, 2012
Last verified: March 2012

February 10, 2009
March 19, 2012
April 2006
December 2012   (final data collection date for primary outcome measure)
Vein occlusion rate [ Time Frame: 5yr ] [ Designated as safety issue: No ]
Vein occlusion rate [ Time Frame: 3yr ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00842296 on ClinicalTrials.gov Archive Site
Status of clinical signs and symptoms of lower limb venous disease [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
Status of clinical signs and symptoms of lower limb venous disease [ Time Frame: 2 yr ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

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 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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Great Saphenous Disease
  • Venous Reflux
Device: RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter
Other Names:
  • CLF
  • CLosureFAST
Treatment
Single Arm with CLF Catheter
Intervention: Device: RF ablation (ClosureFAST)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
396
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00842296
CLF-05-03
No
VNUS Medical Technologies, A Covidien Company
VNUS Medical Technologies, A Covidien Company
Not Provided
Study Director: Kathryn Rumrill Covidien
VNUS Medical Technologies, A Covidien Company
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP