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COMPLETED
NCT07827339
NA

Non-Inferiority Clinical Evaluation of a Novel Varicose Vein Closure Adhesive System for Lower Extremity Varicose Veins

Sponsor: Shanghai TENDFO Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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