Status:
TERMINATED
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small 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 related to the Small Saphenous Vein (SSV) to evaluat...
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 indicated.
- Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
- Have symptoms secondary to Small 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 Deep Venous Thrombosis (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 :
March 29 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02248740
Start Date
September 1 2008
End Date
March 29 2017
Last Update
February 7 2019
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298