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ACTIVE NOT RECRUITING
NCT06387264
NA

Compont - Varicose Veins of the Lower Extremities

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities. The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities. Participants will: Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast. Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.

Official title: Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2023-01-11

Completion Date

2024-12

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DEVICE

Medical Adhesive

Medical Adhesive (produced by Beijing Compont Medical Devices Co., Ltd.) For varicose veins in the main saphenous vein, use 0.1 ml glue for every 3 cm of blood vessels.

DEVICE

ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter

ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by America Medtronic Inc.) The ClosureFast catheter precisely heats a 7 cm vein segment in one 20-second interval.

Locations (1)

Peking University People's Hospital

Beijing, China