NCT06387264

Compont - Varicose Veins of the Lower Extremities

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Varicose Veins of Lower Limb

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-11
• Primary completion: 2024-04-03
• Completion: 2024-12-01
• First posted: 2024-04-29
• Last updated: 2024-09-19

Locations

1 site across 1 country: China