Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein (RECoN)

This study has been withdrawn prior to enrollment.
(Business decision to reevaluate clinical needs.)
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01173419
First received: July 28, 2010
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Varicose Veins
Venous Insufficiency
Device: VNUS RF ClosureFAST
Device: VenaCure EVLT NeverTouch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Angiodynamics, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Presence and intensity of post operative pain between the two treatment groups. [ Time Frame: Evaluated at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Evaluated 2, 7, 14 and 30 days post treatment follow up visits. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Reviewed at 2, 7, 14 and 30 days post treatment follow up visits. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VenaCure EVLT NeverTouch Device: VenaCure EVLT NeverTouch
Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.
Other Names:
  • VenaCure
  • EVLT
  • NeverTouch
Active Comparator: RF ClosureFAST Device: VNUS RF ClosureFAST
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.
Other Name: Closure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01173419

Locations
United States, California
UC Davis Interventional and Vascular Radiology
Sacramento, California, United States, 95817
United States, Florida
Batey Cardiovascular and Vein Center
Bradenton, Florida, United States, 34209
United States, Illinois
Midwest Institute for Minimally Invasive Therapies (MIMIT)
Melrose Park, Illinois, United States, 60160
United States, Michigan
Novi Vein Center
Novi, Michigan, United States, 48377
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Angiodynamics, Inc.
Investigators
Principal Investigator: David Gillespie, MD University of Rochester
  More Information

No publications provided

Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01173419     History of Changes
Other Study ID Numbers: PV-201
Study First Received: July 28, 2010
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Angiodynamics, Inc.:
Great Saphenous Vein

Additional relevant MeSH terms:
Varicose Veins
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014