Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovenous Radiofrequency Ablation Closure System

Group Type EXPERIMENTAL

radiofrequency ablation

Intervention Type DEVICE

ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients

ClosureFast™ Radiofrequency Ablation System

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type DEVICE

ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients

Interventions

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radiofrequency ablation

ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No