ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00842296 |
Recruitment Status :
Completed
First Posted : February 12, 2009
Results First Posted : December 11, 2017
Last Update Posted : March 12, 2018
|
Sponsor:
Medtronic Endovascular
Information provided by (Responsible Party):
Medtronic Endovascular
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 10, 2009 | |||
First Posted Date ICMJE | February 12, 2009 | |||
Results First Submitted Date ICMJE | June 26, 2017 | |||
Results First Posted Date ICMJE | December 11, 2017 | |||
Last Update Posted Date | March 12, 2018 | |||
Study Start Date ICMJE | April 2006 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
Vein occlusion rate [ Time Frame: 3yr ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
Status of clinical signs and symptoms of lower limb venous disease [ Time Frame: 2 yr ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | ClosureFAST - Radiofrequency Great Saphenous Vein Treatment | |||
Official Title ICMJE | ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element | |||
Brief 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Venous Reflux | |||
Intervention ICMJE | Device: RF ablation (ClosureFAST)
Segmental RF Ablation with the CLF catheter
Other Names:
|
|||
Study Arms ICMJE | Experimental: Seg. RF Ablation with CLF catheter
Single Arm with CLF Catheter
Intervention: Device: RF ablation (ClosureFAST)
|
|||
Publications * | Proebstle TM, Möhler T. A longitudinal single-center cohort study on the prevalence and risk of accessory saphenous vein reflux after radiofrequency segmental thermal ablation of great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):265-9. doi: 10.1016/j.jvsv.2014.10.001. Epub 2014 Dec 6. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
326 | |||
Original Actual Enrollment ICMJE |
396 | |||
Actual Study Completion Date ICMJE | May 2012 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00842296 | |||
Other Study ID Numbers ICMJE | CLF-05-03 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
|
|||
Responsible Party | Medtronic Endovascular | |||
Study Sponsor ICMJE | Medtronic Endovascular | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Medtronic Endovascular | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |