Status:
COMPLETED
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Chronic Venous Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02236338
Start Date
September 1 2008
End Date
August 11 2016
Last Update
May 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298