NCT04658901

ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China

Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Acotec Scientific Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower extremity.

Detailed description

This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete closure rate of great saphenous vein at 6 months post-procedure.

Conditions

• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
DEVICE	ERA-C70,ERA-C30 and ERA-G5	use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity
DEVICE	ClosureFast™ and ClosureRFG™	use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-01-01
• Completion: 2022-04-12
• First posted: 2020-12-09
• Last updated: 2022-08-18

Locations

1 site across 1 country: China