Chronic Venous InsufficiencyPhase 4NCT02236338
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
A Phase 4 study testing Ablation of the Incompetent Greater Saphenous Vein, ClosureFAST radiofrequency catheter and EVLT 980nm diode laser system in people with Chronic Venous Insufficiency, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Ablation of the Incompetent Greater Saphenous Vein, ClosureFAST radiofrequency catheter and EVLT 980nm diode laser system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to 11 Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic chronic venous insufficiency.
- Patients in whom endovenous thermal ablation is clinically indicate.
- Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
- Have venous disease that meets CEAP clinical class 2 through 6.
- Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse flow in the saphenous vein >0.5 seconds after calf compression or while standing.
Who cannot join
- Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).
- Have a history of DVT.
- Have a history of hypercoaguability disorder.
- Are pregnant or breastfeeding.
- Are nonambulatory.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial
The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.
Read the detailed description
Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the GSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Ablation of the Incompetent Greater Saphenous Vein, ClosureFAST radiofrequency catheter, EVLT 980nm diode laser system
- Keywords
- chronic venous insufficiency, varicose vein, greater saphenous vein
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of the Incompetent Greater Saphenous VeinProcedure or surgery
For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
ClosureFAST radiofrequency catheterDevice
EVLT 980nm diode laser systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Device: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. Receives: Procedure: Ablation of the Incompetent Greater Saphenous Vein; Device: ClosureFAST radiofrequency catheter |
| Laser Ablation | Active comparator | Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).
Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. Receives: Procedure: Ablation of the Incompetent Greater Saphenous Vein; Device: EVLT 980nm diode laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.
Measured: Annual follow up, up to 75 months
Secondary outcomes (1)
Incidence Rate of Acute Complications
Number of acute complications at one and 6 weeks post intervention
Measured: up to 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2008
- Primary completion11 Aug 2016
- Study completion11 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Sydnor, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236338
- Sponsor's protocol ID
- HM11792
- Status last verified
- Apr 2018
- First submitted
- 2 Sep 2014
- Last updated
- 14 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02236338
- Acronym / sponsor ID
- HM11792
- Conditions
- Chronic Venous Insufficiency
- Keywords
- chronic venous insufficiency, varicose vein, greater saphenous vein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- 11 Aug 2016 (actual)
- Study completion
- 11 Aug 2016 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 14 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.
Detailed description
Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the GSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Procedure: Ablation of the Incompetent Greater Saphenous Vein, Device: ClosureFAST radiofrequency catheterDevice: ClosureFAST radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. |
| Laser Ablation | Active comparator | Procedure: Ablation of the Incompetent Greater Saphenous Vein, Device: EVLT 980nm diode laser systemDevice: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with symptomatic chronic venous insufficiency.
- Patients in whom endovenous thermal ablation is clinically indicate.
- Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
- Have venous disease that meets CEAP clinical class 2 through 6.
- Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse flow in the saphenous vein >0.5 seconds after calf compression or while standing.
Key exclusion criteria (5 listed)
- Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).
- Have a history of DVT.
- Have a history of hypercoaguability disorder.
- Are pregnant or breastfeeding.
- Are nonambulatory.
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 |
|---|---|---|
| Ablation of the Incompetent Greater Saphenous VeinFor each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment. | Procedure or surgery | Laser Ablation, Radiofrequency Ablation |
| ClosureFAST radiofrequency catheter | Device | Radiofrequency Ablation |
| EVLT 980nm diode laser system | Device | Laser Ablation |
Primary outcome
Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.
Time frame: Annual follow up, up to 75 months
1 secondary outcome
Incidence Rate of Acute Complications
Time frame: up to 6 weeks post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Malcolm Sydnor, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ablation of the Incompetent Greater Saphenous Vein, ClosureFAST radiofrequency catheter and EVLT 980nm diode laser system in people with Chronic Venous Insufficiency, run by Virginia Commonwealth University at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. (time frame: Annual follow up, up to 75 months). 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 14 May 2018.