Compont - Varicose Veins of the Lower Extremities

NCT06387264 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Not applicable

Started

2023-01-11

Last updated

2024-09-19

Condition(s) studied

Varicose Veins of Lower Limb

Investigational drug(s) / intervention(s)

Medical AdhesiveClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

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

Primary outcome measure(s)

Clinical success rate — 24 weeks after operation.
At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.

Trial sites (1)

Facility	City	Region	Status
Peking University People's Hospital	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06387264 on ClinicalTrials.gov ↗ ← All trials in China