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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation of the Incompetent Greater Saphenous Vein | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. | Annual follow up, up to 75 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Acute Complications | Number of acute complications at one and 6 weeks post intervention | up to 6 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-procedure Pain | Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain. | During post procedure recovery period in clinic, an expected average of 2 hours after surgery. |
| Incidence of Objective Post-procedure Bruising |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Sydnor, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Ablation | 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. Ablation of the Incompetent Greater Saphenous Vein: 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 catheter |
| FG001 | Laser Ablation | Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. Ablation of the Incompetent Greater Saphenous Vein: 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. EVLT 980nm diode laser system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Ablation | 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. Ablation of the Incompetent Greater Saphenous Vein: 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 catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. | The mean long-term followup in the EVLA group was 44 (12-64) months, and the mean long-term follow-up in the RFA group was 42 (12-75) months. | Posted | Number | percentage of total participants | Annual follow up, up to 75 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency Ablation | 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. Ablation of the Incompetent Greater Saphenous Vein: 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 catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Malcolm Sydnor | Virginia Commonwealth University | (804) 828-0534 | malcolm.sydnor@vcuhealth.org |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| ClosureFAST radiofrequency catheter | Device |
|
| EVLT 980nm diode laser system | Device |
|
Measured with bruising scale, with a range of 1-10 with 10 being the most bruising. |
| During post procedure recovery period in clinic, an expected average of 2 hours after surgery. |
| BG001 | Laser Ablation | Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. Ablation of the Incompetent Greater Saphenous Vein: 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. EVLT 980nm diode laser system |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Laser Ablation | Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. Ablation of the Incompetent Greater Saphenous Vein: 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. EVLT 980nm diode laser system |
|
|
| Secondary | Incidence Rate of Acute Complications | Number of acute complications at one and 6 weeks post intervention | Posted | Number | number of complications | up to 6 weeks post intervention |
|
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|
| Other Pre-specified | Incidence of Post-procedure Pain | Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain. | Posted | Median | Full Range | units on a scale | During post procedure recovery period in clinic, an expected average of 2 hours after surgery. |
|
|
|
| Other Pre-specified | Incidence of Objective Post-procedure Bruising | Measured with bruising scale, with a range of 1-10 with 10 being the most bruising. | Posted | Median | Full Range | units on a scale | During post procedure recovery period in clinic, an expected average of 2 hours after surgery. |
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| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Laser Ablation | Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent greater saphenous vein, using this device. Ablation of the Incompetent Greater Saphenous Vein: 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. EVLT 980nm diode laser system | 0 | 100 | 0 | 100 |
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