Lake Washington Vascular VenaSeal™ Post-Market Evaluation

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

UNKNOWN

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-03-31

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.

Conditions

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Varicose Veins Venous Reflux

Keywords

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Venaseal cyanoacrylate closure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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VenaSeal

Complete closure of previously treated veins will be assessed via ultrasound

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.

Interventions

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Ultrasound

Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Unilateral ultrasound of Limb

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.

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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).

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Gibson, MD

Role: PRINCIPAL_INVESTIGATOR

Lake Washington Vascular, PLLC

Locations

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