Clinical Research Directory
Browse clinical research sites, groups, and studies.
Non-Inferiority Clinical Evaluation of a Novel Varicose Vein Closure Adhesive System for Lower Extremity Varicose Veins
Sponsor: Shanghai TENDFO Medical Technology Co., Ltd.
Summary
A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co., Ltd.) or radiofrequency ablation (RFA).
Official title: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of a Novel Varicose Vein Closure Adhesive System for the Treatment of Lower Extremity Varicose Veins
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
179
Start Date
2023-10-24
Completion Date
2026-04-18
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)
Endovenous delivery of adhesive to the target site in diseased GSV by a tube. Deliver the adhesive in segmental fashion, until the target vein was completely closed.
RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
Endovenous insertion of the ClosureFast RFA catheter into a target site in diseased GSV. Heat is applied to the target vein using radiofrequency energy released by the ClosureRFG™ to ablate the target vein.
Locations (6)
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Jinhua, Zhejiang, China
Ruian People's Hospital
Ruian, Zhejiang, China