NCT02585726

Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)

Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Lake Washington Vascular · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Conditions

• Venous Reflux

Interventions

Type	Name	Description
DEVICE	SP-402 VenaSeal™ Closure System	A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-10-23
• Last updated: 2018-03-16

Locations

1 site across 1 country: United States