Compont - Varicose Veins of the Lower Extremities

Peking University

Status: Active, not recruiting

Conditions: Varicose Veins of Lower Limb

Treatments: Device: Medical Adhesive; Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06387264

2022PHC032

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
• CEAP is graded C2-C6.
• Doppler ultrasound confirmed the patency of deep veins of lower limbs.
• Sign informed consent, voluntarily participate in the trial and follow up as required

Exclusion criteria

• A history of lower extremity deep vein thrombosis or pulmonary embolism
• Recurrent varicose veins
• The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
• The great saphenous vein is severely distorted or tuberculated at the root
• Sepsis or septicemia
• Allergic to n-butyl cyanoacrylate
• The distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm
• Severe cardiopulmonary disease, shock, coma or multiple organ failure
• Lactating or pregnant women
• Participated in other clinical trials within 1 month before surgery
• The researchers considered it unsuitable for inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Medical Adhesive treatment group

Experimental group

Treatment:

Device: Medical Adhesive

Endovenous Radiofrequency Ablation Catheter

Active Comparator group

Treatment:

Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter