Varicose VeinsRECoNNCT01173419
Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein
A study testing VNUS RF ClosureFAST and VenaCure EVLT NeverTouch in people with Varicose Veins and Venous Insufficiency, run by Angiodynamics, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins, Venous Insufficiency
- What is being tested?
- VNUS RF ClosureFAST and VenaCure EVLT NeverTouch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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).
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Batey Cardiovascular and Vein Center
Bradenton, Florida, 34209
Midwest Institute for Minimally Invasive Therapies (MIMIT)
Melrose Park, Illinois, 60160
NYU Langone Medical Center
New York, New York, 10016
Novi Vein Center
Novi, Michigan, 48377
University of Rochester Medical Center
Rochester, New York, 14642
UC Davis Interventional and Vascular Radiology
Sacramento, California, 95817
About this study
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
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.
Read the 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.
- Conditions
- Varicose Veins, Venous Insufficiency
- Being tested
- VNUS RF ClosureFAST, VenaCure EVLT NeverTouch
- Keywords
- Great Saphenous Vein
- Medical subject headings
- Varicose Veins, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNUS RF ClosureFASTDevice
Also called Closure
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.
VenaCure EVLT NeverTouchDevice
Also called VenaCure, EVLT, NeverTouch
Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.
| Study group | Role | What they receive |
|---|---|---|
| VenaCure EVLT NeverTouch | Active comparator | Not described Receives: Device: VenaCure EVLT NeverTouch |
| RF ClosureFAST | Active comparator | Not described Receives: Device: VNUS RF ClosureFAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post operative adverse events/ effects between the two treatment groups.
Measured: 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.
Measured: 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.
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.
Measured: 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.
A blinded healthcare professional (selected by the PI at each site) will evaluate the subject at the designated timepoints.
Measured: 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.
Measured: Reviewed at 2, 7, 14 and 30 days post treatment follow up visits.
Evaluation of subject quality of life between the two treatment groups.
Measured: Completed at 2, 7, 14 and 30 days and 6 and 12 months post treatment follow up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2012 (estimated)
Why it stopped: Business decision to reevaluate clinical needs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gillespie, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173419
- Sponsor's protocol ID
- PV-201
- Acronym
- RECoN
- Status last verified
- Jul 2012
- First submitted
- 28 Jul 2010
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01173419
- Acronym / sponsor ID
- RECoN / PV-201
- Conditions
- Varicose Veins, Venous Insufficiency
- Keywords
- Great Saphenous Vein
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision to reevaluate clinical needs.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VenaCure EVLT NeverTouch | Active comparator | Device: VenaCure EVLT NeverTouch |
| RF ClosureFAST | Active comparator | Device: VNUS RF ClosureFAST |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- male or female,
- 18 to 80 years of age,
- have documented symptomatic GSV disease defined by any of the following:
- C2 disease
- C3 disease
Key exclusion criteria (13 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNUS RF ClosureFASTAlso: ClosureVNUS® 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. | Device | RF ClosureFAST |
| VenaCure EVLT NeverTouchAlso: VenaCure, EVLT, NeverTouchEndovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins. | Device | VenaCure EVLT NeverTouch |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
Related trials for Varicose Veins
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gillespie, MD principal investigator
University of Rochester
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VNUS RF ClosureFAST and VenaCure EVLT NeverTouch in people with Varicose Veins and Venous Insufficiency, run by Angiodynamics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.