Early Outcome of Mechanochemical Endovenous Ablation

Study Overview
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Brief Summary
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More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.

Official Title
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Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study

Conditions
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Varicosis

Intervention / Treatment
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* Device: ClariVein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insufficiency of the GSV Ultrasound criteria for endovenous treatment have been met: Diameter GSV between 3-12 mm No thrombus present at the GSV part to be treated Signed informed consent Patient willing to present at follow-up visits Age > 18 jaar Exclusion Criteria: Patient is unable to give informed consent Patient unable to present at all follow-up visits Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation Pregnancy and breast feeding Known allergy/ contra indication for sclerotherapy Previous ipsilateral surgical treatment of varicose veins Deep venous vein thrombosis in medical history Anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GSV insufficiency<br>Patients with insufficiency of the greater saphenous vein (GSV) will be included. | Device: ClariVein<br>* Using the ClariVein device, the GSV will be occluded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate | The percentage of GSV occluded | 30 days, 1, 2, and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status | Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points. The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. | 30 days, 1, 2, and 5 years | 
| Disease related quality of life | Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points. | 30 days, 1, 2, and 5 years | 
| Pain score during procedure | The pain will be scored during procedure using the VAS score. | peri-procedural | 
| 2-weeks post-procedure pain score | The pain will be scored daily for two weeks after the procedure using the VAS score. | two weeks | 
| recovery time | The time (in days) after the procedure until patients were able to restart daily activity/daily work | two weeks | 
| procedural complications | all complications related to the procedure will be evaluated at the mentioned time points. | during procedure | 
| post-procedural complications | all complications related to the procedure will be evaluated at the mentioned time points. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSV, insufficiency, ClariVein device, safety, efficacy, QOL