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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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