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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.
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 ClosureFastâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovenous Radiofrequency Ablation Closure System | Experimental |
| |
| ClosureFastâ„¢ Radiofrequency Ablation System | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation | Device | ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular closure rate at 6 months after the operation | Calculation method: completely closed patients / total cases of subjects in the same group x 100%. Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| CEAP | The CEAP is an elaborate scoring system for varicose veins and other disorders from venous insufficiency. It has been developed to determine the severity of the condition for diagnosis and treatment point of view. CEAP stands for: Clinical Etiopathological Anatomical Pathophysiological | 6 months |
| Technical success rate |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of serious adverse events within 6 months after surgery | 6 months | |
| Rate of adverse events within 6 months after surgery | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China | ||
| Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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The device is delivered in place and withdrawn smoothly, and the target diseased blood vessel is immediately examined by ultrasound without blood flow. |
| 6 months |
| Evaluation of the use of devices | For endovenous radiofrequency closure catheter: evaluation on the degree of device flexibility, crossability, accuracy, usability (subjective evaluation scale: excellent, good and poor) For endovenous radiofrequency closure generator: evaluation on applicability,accuracy of identifying catheter version, stability in the procedure(subjective evaluation: yes or no) | 6 months |
| VCSS | Changes from baseline in venous clinical severity score (VCSS) (0-30, higher scores mean a worse outcome) in outpatient services. the VCSS was derived by the American Venous Forum from the CEAP classification and provides means by which clinical outcomes in venous disease can be monitored in time.Compared to the CEAP, VCSS is said to be more responsive to changes in disease severity, thus making it great for progressive rankings. It proved good inter and intra observer reproducibility and is often cited in quality of life assessments | 6 months |
| Hangzhou |
| Zhejiang |
| 310006 |
| China |
| ZheJiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| The Fourth Affiliated Hospital ,Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310052 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 322000 | China |