Trial Outcomes & Findings for Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein (NCT NCT02248740)
NCT ID: NCT02248740
Last Updated: 2019-02-07
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
At 10 years after treatment.
Results posted on
2019-02-07
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 small saphenous vein, using this device.
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
|
Laser Ablation
Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).
Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein
Baseline characteristics by cohort
| Measure |
Radiofrequency Ablation
n=18 Participants
Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).
Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
|
Laser Ablation
n=18 Participants
Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).
Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.
Ablation of the incompetent small saphenous vein: For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 10 years after treatment.Population: No study data was collected prior to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 and 6 weeks post intervention.Population: No study data was collected prior to study termination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.Population: No study data was collected prior to study termination.
Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10. Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.
Outcome measures
Outcome data not reported
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