Recruiting

VenaSeal™

Sponsor:

Lake Washington Vascular

Code:

NCT04146168

Conditions

Varicose Veins

Venous Reflux

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrasound

Study Details

Brief 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

Conditions

Varicose Veins

Venous Reflux

Study ID

NCT04146168

Start date

Nov, 2019

Status verified date

Oct, 2019

Completion date

Mar, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

124 participants

Anticipated

Interventions and Outcome Measures

Arms

VenaSeal

Complete closure of previously treated veins will be assessed via ultrasound

Interventions

Ultrasound

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

Primary outcome measure

  • Complete Closure of Target Vein(s) at 3 years after index treatment [ Time Frame: 3 years post treatment ]

Central Contacts and Locations

Central contacts

Kim D Glorieux, BS, BS, CCRC

425-453-1772kimg@lkwv.com

Locations

Lake Washington Vascular

Recruiting

Bellevue, Washington, United States, 98004

Contacts

Kim Glorieux, BS, BS, CCRC

425-453-1772kimg@lkwv.com

Principal Investigator:

Kathleen Gibson, MD

Lake Washington Vascular

Recruiting

Issaquah, Washington, United States, 98027

Contacts

Kim Glorieux, BS, BS, CCRC

425-453-1772kimg@lkwv.com

Principal Investigator:

Kathleen Gibson, MD

Lake Washington Vascular

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Kim Glorieux, BS, BS, CCRC

425-453-1772kimg@lkwv.com

Principal Investigator:

Kathleen Gibson, MD

More Information

Sponsor

Lake Washington Vascular

Last update posted

Oct 31, 2019

Last verified

Oct, 2019

Keywords

  • Venaseal
  • cyanoacrylate closure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lake Washington Vascular on 2019-10-31.