Phase 4
Completed N=200
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
Chronic Venous Insufficiency
Source: ClinicalTrials.gov NCT02236338 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. — 79.3; 77.5 percentage of total participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment. |
79.3; 77.5 | — |
| SECONDARY Incidence Rate of Acute Complications |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02236338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.