Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

NCT02236338 | Completed Phase 4 Results

• 1 other identifier: HM11792
• Study Type: interventional
• Target: 200
• 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, in an effort 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; greater saphenous vein

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.

  Annual follow up, up to 75 months

Secondary Outcomes (1)

• Incidence Rate of Acute Complications

  up to 6 weeks post intervention

Other Outcomes (2)

• Incidence of Post-procedure Pain

  During post procedure recovery period in clinic, an expected average of 2 hours after surgery.

• Incidence of Objective Post-procedure Bruising

  During post procedure recovery period in clinic, an expected average of 2 hours after surgery.

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 greater saphenous vein, using this device.

Procedure: Ablation of the Incompetent Greater Saphenous Vein; Device: ClosureFAST radiofrequency catheter

Laser Ablation

ACTIVE COMPARATOR

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

Procedure: Ablation of the Incompetent Greater Saphenous Vein; Device: EVLT 980nm diode laser system

Interventions

Ablation of the Incompetent Greater Saphenous Vein PROCEDURE

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.

Laser Ablation; Radiofrequency Ablation

ClosureFAST radiofrequency catheter DEVICE

Radiofrequency Ablation

EVLT 980nm diode laser system DEVICE

Laser 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 indicate.
• Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
• Have venous disease that meets CEAP clinical class 2 through 6.
• Have symptoms secondary to Greater 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 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 University

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 10, 2014
• Study Start: September 1, 2008
• Primary Completion: August 11, 2016
• Study Completion: August 11, 2016
• Last Updated: May 14, 2018
• Results First Posted: May 14, 2018

Record last verified: 2018-04

Locations

US (1)