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

Varicose Veins Clinical Trial

— LAST  

Official title:

Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046967
• Other study ID #: ErasmusMC
• Status: Completed
• Phase: N/A
• First received: January 23, 2014
• Last updated: January 27, 2014
• Start date: November 2009
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Leg With Long Saphenous Vein Distribution

Intervention

Procedure:
• Endovenous laser ablation with 940 nm bare fiber
Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
• Endovenous steam ablation with steam vein sclerosis system.
Endovenous steam ablation with steam vein sclerosis.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.		12 weeks	Yes
Secondary	Minor complications: ecchymosis, pain and hyperpigmentation.		12 weeks	Yes
Secondary	Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).		12 weeks	No
Secondary	Treatment satisfaction		2 weeks	No
Secondary	Pain score		2 weeks	No
Secondary	Venous Clinical Severity Score (VCSS)		12 weeks	No