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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Varicose Veins Varicose Veins of Leg With Long Saphenous Vein Distribution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovenous laser ablation

Endovenous laser ablation with 940 nm bare fiber.

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation with 940 nm bare fiber

Intervention Type PROCEDURE

Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.

Endovenous steam ablation

Endovenous steam ablation with steam vein sclerosis system.

Group Type ACTIVE_COMPARATOR

Endovenous steam ablation with steam vein sclerosis system.

Intervention Type PROCEDURE

Endovenous steam ablation with steam vein sclerosis.

Interventions

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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.

Intervention Type PROCEDURE

Endovenous steam ablation with steam vein sclerosis system.

Endovenous steam ablation with steam vein sclerosis.

Intervention Type PROCEDURE

Other Intervention Names

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EVLT EVLA SVS EVSA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No