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

NCT ID: NCT02248740

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2017-03-29

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 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 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.

Conditions

Chronic Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency Ablation

Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).

Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

Group Type: ACTIVE_COMPARATOR

Ablation of the incompetent small saphenous vein

Intervention Type: PROCEDURE

For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.

Laser Ablation

Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).

Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

Group Type: ACTIVE_COMPARATOR

Ablation of the incompetent small saphenous vein

Intervention Type: PROCEDURE

For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.

Interventions

Ablation of the incompetent small saphenous vein

For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 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 Deep Venous Thrombosis (DVT).
• Have a history of hypercoaguability disorder.
• Are pregnant or breastfeeding.
• Are nonambulatory.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Sydnor, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HM11844

Identifier Type: -

Identifier Source: org_study_id