Trial Outcomes & Findings for Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein (NCT NCT02236338)
NCT ID: NCT02236338
Last Updated: 2018-05-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
Annual follow up, up to 75 months
Results posted on
2018-05-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
Baseline characteristics by cohort
| Measure |
Radiofrequency Ablation
n=100 Participants
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
|
Laser Ablation
n=100 Participants
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
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
48.5 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
78 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Annual follow up, up to 75 monthsPopulation: 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.
Outcome measures
| Measure |
Radiofrequency Ablation
n=87 Participants
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
|
Laser Ablation
n=89 Participants
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
|
|---|---|---|
|
Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.
|
79.3 percentage of total participants
|
77.5 percentage of total participants
|
SECONDARY outcome
Timeframe: up to 6 weeks post interventionNumber of acute complications at one and 6 weeks post intervention
Outcome measures
| Measure |
Radiofrequency Ablation
n=100 Participants
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
|
Laser Ablation
n=100 Participants
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
|
|---|---|---|
|
Incidence Rate of Acute Complications
|
0 number of complications
|
0 number of complications
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During post procedure recovery period in clinic, an expected average of 2 hours after surgery.Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.
Outcome measures
| Measure |
Radiofrequency Ablation
n=100 Participants
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
|
Laser Ablation
n=100 Participants
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
|
|---|---|---|
|
Incidence of Post-procedure Pain
|
1 units on a scale
Interval 1.0 to 10.0
|
3 units on a scale
Interval 1.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During post procedure recovery period in clinic, an expected average of 2 hours after surgery.Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.
Outcome measures
| Measure |
Radiofrequency Ablation
n=100 Participants
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
|
Laser Ablation
n=100 Participants
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
|
|---|---|---|
|
Incidence of Objective Post-procedure Bruising
|
2 units on a scale
Interval 1.0 to 9.0
|
3 units on a scale
Interval 1.0 to 8.0
|
Adverse Events
Radiofrequency Ablation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laser Ablation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place