Lake Washington Vascular VenaSeal™ Post-Market Evaluation

Status unconfirmed

Conditions studied: Varicose Veins, Venous Reflux

In brief

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

Key facts

Study ID

NCT04146168

Run by

Lake Washington Vascular

People needed

124

Starts

2019-11-01

Expected to finish

2020-03-01

Last updated by the study team

2019-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Lake Washington Vascular — Bellevue, Washington, United States (enrolling)
• Lake Washington Vascular — Issaquah, Washington, United States (enrolling)
• Lake Washington Vascular — Kirkland, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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