CompletedNot Applicable

Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

China176 participantsStarted 2021-03-24

Plain-language summary

The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18-80 years old, no gender limit.
✓. Great saphenous varicose, CEAP grade C2-C6.
✓. The diameter of the diseased vein is ≥2mm, ≤15mm.
✓. Expected survival period ≥ 6 months.
✓. The informed consent form can be signed by the patient or the legal representative.

Exclusion criteria

✕. Are pregnant or breastfeeding.
✕. Participating in clinical trials of other devices or drugs.
✕. Deep vein thrombosis in the affected limb.
✕. Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L).
✕. Acute thrombosis in the main saphenous vein of the affected limb.
✕. The investigator judged that it is not suitable to participate in the clinical trial.

What they're measuring

Vascular closure rate at 6 months after the operation

Timeframe: 6 months

Trial details

NCT IDNCT04671641

SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-01

View on ClinicalTrials.gov More Varicose Veins trials