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

NCT01173419 | Withdrawn

• 1 other identifier: PV-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

Varicose Veins; Venous Insufficiency

Keywords

Great Saphenous Vein

Outcome Measures

Primary Outcomes (1)

• Incidence of post operative adverse events/ effects between the two treatment groups.

  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 Outcomes (5)

• Evaluation of GSV closure and incidence of DVT via duplex ultrasound between the two treatment groups.

  Evaluated at 7 and 30 days post treatment and 6 and 12 months post treatment follow up visits.

• Presence and intensity of post operative pain between the two treatment groups.

  Evaluated at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits.

• Presence and intensity of post operative ecchymosis between the two treatment groups.

  Evaluated 2, 7, 14 and 30 days post treatment follow up visits.

• Use of Analgesics within the 30 days post treatment between the two treatment groups.

  Reviewed at 2, 7, 14 and 30 days post treatment follow up visits.

• Evaluation of subject quality of life between the two treatment groups.

  Completed at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits.

Study Arms (2)

VenaCure EVLT NeverTouch

ACTIVE COMPARATOR

Device: VenaCure EVLT NeverTouch

RF ClosureFAST

ACTIVE COMPARATOR

Device: VNUS RF ClosureFAST

Interventions

VNUS RF ClosureFAST DEVICE

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.

Also known as: Closure

RF ClosureFAST

VenaCure EVLT NeverTouch DEVICE

Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.

Also known as: VenaCure, EVLT, NeverTouch

VenaCure EVLT NeverTouch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female,
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (6)

UC Davis Interventional and Vascular Radiology

Sacramento, California, 95817, United States

Location

Batey Cardiovascular and Vein Center

Bradenton, Florida, 34209, United States

Location

Midwest Institute for Minimally Invasive Therapies (MIMIT)

Melrose Park, Illinois, 60160, United States

Location

Novi Vein Center

Novi, Michigan, 48377, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Gillespie, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

US (6)