Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein (RECoN)
Primary Purpose
Varicose Veins, Venous Insufficiency
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VNUS RF ClosureFAST
VenaCure EVLT NeverTouch
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Great Saphenous Vein
Eligibility Criteria
Inclusion Criteria:
- male or female,
- 18 to 80 years of age,
- have documented symptomatic GSV disease defined by any of the following:
- C2 disease
- C3 disease
- C4A, C4B disease
- C5 disease
- C6 disease
- have not been previously treated for GSV,
- have multilevel venous reflux in the great saphenous vein greater than 0.5 seconds after distal compression/ release in the standing position,
- have palpable dorsalis pedis/ anterior tibial pulse or ABI >0.9 (unless calcified pressures) at screening,
- are able to comply with the protocol requirements,
- are able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion Criteria:
- has had a previous venous intervention on the same leg as planned current treatment,
- are in a known hypercoagulable state,
- have deep vein thrombosis or a history of deep vein thrombosis,
- have thrombus within the last three months in the vein segment to be treated,
- have an aneurysmal section in the vein segment to be treated (aneurysm is defined as 2 times greater than the adjacent vein),
- are not able to ambulate,
- have non staged adjunctive procedures such as sclerotherapy and/ or ambulatory phlebectomy. May elect to stage the procedure from the initial script, and not treat before the 30 day follow up visit is completed.
- are, in the opinion of the investigator, unable to comply with the schedule and protocol evaluations,
- are currently pregnant or breast feeding,
- have a known malignancy other than skin cancer,
- current use of anticoagulant medication,
- have any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol,
- has had treatment with any investigational agent within 30 days of visit 1.
Sites / Locations
- UC Davis Interventional and Vascular Radiology
- Batey Cardiovascular and Vein Center
- Midwest Institute for Minimally Invasive Therapies (MIMIT)
- Novi Vein Center
- NYU Langone Medical Center
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VenaCure EVLT NeverTouch
RF ClosureFAST
Arm Description
Outcomes
Primary Outcome Measures
Incidence of post operative adverse events/ effects between the two treatment groups.
Secondary Outcome Measures
Evaluation of GSV closure and incidence of DVT via duplex ultrasound between the two treatment groups.
Presence and intensity of post operative pain between the two treatment groups.
The VAS scale for pain will be used through the 30 day follow up time period. The questionnaires for quality of life will be used for each of the visits including the 6 and 12 month follow up visits.
Presence and intensity of post operative ecchymosis between the two treatment groups.
A blinded healthcare professional (selected by the PI at each site) will evaluate the subject at the designated timepoints.
Use of Analgesics within the 30 days post treatment between the two treatment groups.
Evaluation of subject quality of life between the two treatment groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01173419
Brief Title
Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein
Acronym
RECoN
Official Title
A Multi-Center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Subjects Comparing the NeverTouch Versus the RF ClosureFAST Methods of Treatment of the Great Saphenous Vein
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision to reevaluate clinical needs.
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiodynamics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi center, randomized, comparison study using two already cleared methods of treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for treatment of the GSV. Evaluation of post operative pain and bruising, quality of life assessments, adverse event assessments, confirmation of long term GSV closure, use of medications are criteria that will be evaluated during the course of this study.
Detailed Description
Some form of venous insufficiency affects up to 25% of men and 40% of women in the United States. While most persons seek treatment because varicose veins are unsightly, most will also experience symptoms such as aching pain, night cramps, leg fatigue, leg heaviness or leg restlessness. If left untreated, nearly 50% of patients with significant superficial venous insufficiency will experience chronic venous insufficiency characterized by lower extremity swelling, eczema, pigmentation, hemorrhage and ulceration.
This is a multicenter, prospective, randomized study in subjects with symptomatic venous insufficiency of the great saphenous vein. Subjects evaluated for participation will be those who, prior to the first visit, have elected to receive invasive treatment for the GSV insufficiency and have already received conservative treatment (i.e. use of compression hose).
Subjects will be randomized to receive one of two methods of treatment. VenaCure EVLT NeverTouch method of treatment or the RF ClosureFAST method of treatment.
Follow up visits will take place at 2, 7, 14 and 30 days post treatment where questionnaires (SF-36, CIVI Q2, Visual Analogue Scale), evaluation of GSV closure via duplex ultrasound (7 day and 30 day only), evaluation of ecchymosis, physician (or their designee) evaluation of venous disease (CEAP assessment and VCSS assessment), assessments of adverse events and review of concomitant medications (use of analgesics and other medications)will take place. These same evaluations with the exception of the use of the Visual Analogue Scale and the Ecchymosis evaluation will also take place at the 6 month and 12 month follow up visit timepoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Venous Insufficiency
Keywords
Great Saphenous Vein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VenaCure EVLT NeverTouch
Arm Type
Active Comparator
Arm Title
RF ClosureFAST
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
VNUS RF ClosureFAST
Other Intervention Name(s)
Closure
Intervention Description
VNUS® RF ClosureFAST is a minimally invasive varicose vein treatment procedure that uses radiofrequency energy (electricity) to heat, collapse and seal off the targeted blood vessels.
Intervention Type
Device
Intervention Name(s)
VenaCure EVLT NeverTouch
Other Intervention Name(s)
VenaCure, EVLT, NeverTouch
Intervention Description
Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.
Primary Outcome Measure Information:
Title
Incidence of post operative adverse events/ effects between the two treatment groups.
Time Frame
Evaluated on the day of treatment (post treatment), 2, 7, 14, and 30 days and 6 and 12 months post treatment follow up visits.
Secondary Outcome Measure Information:
Title
Evaluation of GSV closure and incidence of DVT via duplex ultrasound between the two treatment groups.
Time Frame
Evaluated at 7 and 30 days post treatment and 6 and 12 months post treatment follow up visits.
Title
Presence and intensity of post operative pain between the two treatment groups.
Description
The VAS scale for pain will be used through the 30 day follow up time period. The questionnaires for quality of life will be used for each of the visits including the 6 and 12 month follow up visits.
Time Frame
Evaluated at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits.
Title
Presence and intensity of post operative ecchymosis between the two treatment groups.
Description
A blinded healthcare professional (selected by the PI at each site) will evaluate the subject at the designated timepoints.
Time Frame
Evaluated 2, 7, 14 and 30 days post treatment follow up visits.
Title
Use of Analgesics within the 30 days post treatment between the two treatment groups.
Time Frame
Reviewed at 2, 7, 14 and 30 days post treatment follow up visits.
Title
Evaluation of subject quality of life between the two treatment groups.
Time Frame
Completed at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female,
18 to 80 years of age,
have documented symptomatic GSV disease defined by any of the following:
C2 disease
C3 disease
C4A, C4B disease
C5 disease
C6 disease
have not been previously treated for GSV,
have multilevel venous reflux in the great saphenous vein greater than 0.5 seconds after distal compression/ release in the standing position,
have palpable dorsalis pedis/ anterior tibial pulse or ABI >0.9 (unless calcified pressures) at screening,
are able to comply with the protocol requirements,
are able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion Criteria:
has had a previous venous intervention on the same leg as planned current treatment,
are in a known hypercoagulable state,
have deep vein thrombosis or a history of deep vein thrombosis,
have thrombus within the last three months in the vein segment to be treated,
have an aneurysmal section in the vein segment to be treated (aneurysm is defined as 2 times greater than the adjacent vein),
are not able to ambulate,
have non staged adjunctive procedures such as sclerotherapy and/ or ambulatory phlebectomy. May elect to stage the procedure from the initial script, and not treat before the 30 day follow up visit is completed.
are, in the opinion of the investigator, unable to comply with the schedule and protocol evaluations,
are currently pregnant or breast feeding,
have a known malignancy other than skin cancer,
current use of anticoagulant medication,
have any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol,
has had treatment with any investigational agent within 30 days of visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gillespie, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Interventional and Vascular Radiology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Batey Cardiovascular and Vein Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Midwest Institute for Minimally Invasive Therapies (MIMIT)
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Novi Vein Center
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein
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