Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

Not Applicable

Completed

• Conditions: Varicose Veins of Leg With Long Saphenous Vein Distribution; Varicose Veins
• Interventions: Procedure: Endovenous laser ablation with 940 nm bare fiber; Procedure: Endovenous steam ablation with steam vein sclerosis system.

• Registration Number: NCT02046967
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

Detailed Description

The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Study First Posted: 2014-01-28
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Patients over 18 years old
• Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 s, and diameter of vein > 0.5 cm
• Symptoms of chronic venous insufficiency
• No prior treatment of the insufficient GSV
• Informed consent

Exclusion Criteria

• Acute deep or superficial vein thrombosis
• Agenesis of deep vein system
• Vascular malformation or syndrome
• Post-thrombotic syndrome, occlusive type
• Pregnancy
• Immobility
• Allergy to lidocaine
• Arterial insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovenous laser ablation	Endovenous laser ablation with 940 nm bare fiber	Endovenous laser ablation with 940 nm bare fiber.
Endovenous steam ablation	Endovenous steam ablation with steam vein sclerosis system.	Endovenous steam ablation with steam vein sclerosis system.

Primary Outcome Measures

Name	Time	Method
Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks.	52 weeks

Secondary Outcome Measures

Name	Time	Method
Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.	12 weeks
Minor complications: ecchymosis, pain and hyperpigmentation.	12 weeks
Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).	12 weeks
Treatment satisfaction	2 weeks
Pain score	2 weeks
Venous Clinical Severity Score (VCSS)	12 weeks

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands