Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small

Status Terminated

Clinical Trial 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 evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

Clinical Trial 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 second most common cause is a refluxing or incompetent Small Saphenous Vein (SSV). 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 SSV 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 SSV 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02248740
Study type	Interventional
Source	Virginia Commonwealth University
Contact
Status	Terminated
Phase	Phase 4
Start date	September 2008
Completion date	March 29, 2017

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02462096` - A Feasibility Study of the ReLeaf Catheter System	N/A
Enrolling by invitation	`NCT05504070` - Venclose digiRF System Post Market Study	N/A
Completed	`NCT05507346` - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema	N/A
Recruiting	`NCT05622500` - Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease	N/A
Completed	`NCT03283800` - Copper Impact on Venous Insufficiency and Lipodermatosclerosis	N/A
Completed	`NCT01501188` - Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency	Phase 1
Completed	`NCT02236338` - Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein	Phase 4
Recruiting	`NCT05982405` - Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency	N/A
Completed	`NCT05383469` - Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency	N/A
Completed	`NCT06238791` - Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Withdrawn	`NCT02559427` - SPA Therapy in the Treatment of Sleep Apnea Syndrome	N/A
Completed	`NCT02346058` - Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins	Phase 4
Active, not recruiting	`NCT05926830` - Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study	N/A
Withdrawn	`NCT05047302` - Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System-Canada	N/A
Active, not recruiting	`NCT04339075` - Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Active, not recruiting	`NCT04580160` - Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System	N/A
Not yet recruiting	`NCT02927483` - Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency	Phase 3
Completed	`NCT02015221` - Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort	N/A
Completed	`NCT02050061` - Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life	N/A
Completed	`NCT01432795` - Practicability of Gliding Aids for Medical Compression Stockings	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms