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
  Purpose

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.


Condition Intervention Phase
Great Saphenous Disease
Venous Reflux
Device: RF ablation (ClosureFAST)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

Further study details as provided by VNUS Medical Technologies, A Covidien Company:

Primary Outcome Measures:
  • Vein occlusion rate [ Time Frame: 5yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Status of clinical signs and symptoms of lower limb venous disease [ Time Frame: 5 yr ] [ Designated as safety issue: No ]

Enrollment: 396
Study Start Date: April 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
Single Arm with CLF Catheter
Device: RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter
Other Names:
  • CLF
  • CLosureFAST

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842296

Sponsors and Collaborators
VNUS Medical Technologies, A Covidien Company
Investigators
Study Director: Kathryn Rumrill Covidien
  More Information

No publications provided

Responsible Party: VNUS Medical Technologies, A Covidien Company
ClinicalTrials.gov Identifier: NCT00842296     History of Changes
Other Study ID Numbers: CLF-05-03
Study First Received: February 10, 2009
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by VNUS Medical Technologies, A Covidien Company:
GSV
RadioFrequency

ClinicalTrials.gov processed this record on August 28, 2014