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

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02248740
• Other study ID #: HM11844
• Status: Terminated
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: March 29, 2017

Study information

• Verified date: September 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Pain and Bruising	Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10.; Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators.	During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.
Primary	Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.		At 10 years after treatment.
Secondary	Incidence Rate of Acute Complications		1 and 6 weeks post intervention.