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

NCT02248740 | Terminated Phase 4 Results

• 1 other identifier: HM11844
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Keywords

chronic venous insufficiency; varicose vein; small saphenous vein

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.

  At 10 years after treatment.

Secondary Outcomes (1)

• Incidence Rate of Acute Complications

  1 and 6 weeks post intervention.

Other Outcomes (1)

• Incidence of Pain and Bruising

  During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.

Study Arms (2)

Radiofrequency Ablation

ACTIVE COMPARATOR

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.

Procedure: Ablation of the incompetent small saphenous vein

Laser Ablation

ACTIVE COMPARATOR

Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY). Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

Procedure: Ablation of the incompetent small saphenous vein

Interventions

Ablation of the incompetent small saphenous vein 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; Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Malcolm Sydnor
• Organization: Virginia Commonwealth Univeristy

malcolm.sydnor@vcuhealth.org

(804) 828-0534

Study Officials

• Malcolm Sydnor, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2008
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: February 7, 2019
• Results First Posted: February 7, 2019

Record last verified: 2018-09

Locations

US (1)