Status:
COMPLETED
Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
Lead Sponsor:
Suzhou Hengruihongyuan Medical Technology Co. LTD
Conditions:
Varicose Veins
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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. fo...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04671641
Start Date
March 24 2021
End Date
July 1 2022
Last Update
June 25 2025
Active Locations (5)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
2
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
3
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
4
The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052