NCT02236338

Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein: A Prospective Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. The most common cause is a refluxing or incompetent Greater Saphenous Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the GSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
PROCEDURE	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.
DEVICE	ClosureFAST radiofrequency catheter
DEVICE	EVLT 980nm diode laser system

Timeline

• Start date: 2008-09-01
• Primary completion: 2016-08-11
• Completion: 2016-08-11
• First posted: 2014-09-10
• Last updated: 2018-05-14
• Results posted: 2018-05-14

Locations

1 site across 1 country: United States