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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovenous laser ablation | Active Comparator | Endovenous laser ablation with 940 nm bare fiber. |
|
| Endovenous steam ablation | Active Comparator | Endovenous steam ablation with steam vein sclerosis system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovenous laser ablation with 940 nm bare fiber | Procedure | Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renate R van den Bos, MD, PhD | Erasmus Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | 3015 CA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24981585 | Derived | van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. 2014 Aug;101(9):1077-83. doi: 10.1002/bjs.9580. Epub 2014 Jun 30. |
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|
| Endovenous steam ablation with steam vein sclerosis system. | Procedure | Endovenous steam ablation with steam vein sclerosis. |
|
|
| 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 |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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