Lake Washington Vascular VenaSeal™ Post-Market Evaluation

Last updated: October 30, 2019
Sponsor: Lake Washington Vascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Varicose Veins

Occlusions

Treatment

N/A

Clinical Study ID

NCT04146168
2019-02
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or anycombination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred atleast 30 months prior to study; 4. Ability to understand the requirements of the study andto provide informed consent.

Exclusion

Exclusion Criteria:

  1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease intargeted vein segment after Venaseal closure; 2. Patients in whom index procedureinformation is unavailable; 3. Patients unwilling to undergo ultrasound evaluation andclinical examination of the previously treated limb; 4. Limbs that were treated in theVeClose trial (patients who participated in VeClose and later had contralateral limbtreatment will be included).

Study Design

Total Participants: 124
Study Start date:
November 01, 2019
Estimated Completion Date:
March 31, 2020

Study Description

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.

Connect with a study center

  • Lake Washington Vascular

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Lake Washington Vascular

    Issaquah, Washington 98027
    United States

    Active - Recruiting

  • Lake Washington Vascular

    Kirkland, Washington 98034
    United States

    Active - Recruiting

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