Lake Washington Vascular VenaSeal™ Post-Market Evaluation

Study Overview
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Brief Summary
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New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System

Detailed Description
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New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.

Official Title
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Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation

Conditions
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Varicose Veins, Venous Reflux

Intervention / Treatment
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* Diagnostic Test: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent. - Exclusion Criteria: 1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included). -

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| VenaSeal<br>Complete closure of previously treated veins will be assessed via ultrasound | Diagnostic Test: Ultrasound<br>* Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.<br>* Other names: Unilateral ultrasound of Limb;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Closure of Target Vein(s) at 3 years after index treatment | Complete closure is defined as Doppler Ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm. | 3 years post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous disease severity assessed via Venous Clinical Severity Score | Assessed via the revised Venous Clinical Severity Score (rVCSS). The rVCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration, and inflammation. | 3 years post treatment | 
| Clinical Severity via Varicose Vein Questionnaire (AVVQ) | Assessed via Aberdeen Varicose Vein Questionnaire (AVVQ) is a disease specific 13 item questionnaire is used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and the need to take pain medication. | 3 years post treatment | 
| Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire | Assessed via EQ-5D Questionnaire. The EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The health state today question provides an overall assessment along a 20 cm visual analog scale (VAS) with a range from 0 (worst imaginable health state) to 100 (best imaginable health state). | 3 years post treatment | 
| Need for adjunctive treatments | Either at the index procedure or at any point following the index procedure | 3 years post treatment | 
| Health care utilization | Via chart review and patient questionnaire | 3 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venaseal, cyanoacrylate closure