Clinical trial NCT04671641: Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
Official title: Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. for the treatment of varicose veins.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vascular closure rate at 6 months after the operation
timeFrame: 6 months
Secondary outcomes:
measure: CEAP
timeFrame: 6 months
measure: Technical success rate
timeFrame: 6 months
measure: Evaluation of the use of devices
timeFrame: 6 months
measure: VCSS
timeFrame: 6 months
Other outcomes:
measure: Rate of serious adverse events within 6 months after surgery
timeFrame: 6 months
measure: Rate of adverse events within 6 months after surgery
timeFrame: 6 months
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: ZheJiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: