Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

Hengruihongyuan Medical Technology

Status: Completed

Conditions: Varicose Veins

Treatments: Device: radiofrequency ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04671641

RFS 1.0

Details and patient eligibility

About

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.

Full description

In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.

Enrollment: 176 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Endovenous Radiofrequency Ablation Closure System

Experimental group

Treatment:

Device: radiofrequency ablation

ClosureFast™ Radiofrequency Ablation System

Active Comparator group

Treatment:

Device: radiofrequency ablation