Varicose VeinsNCT04671641
Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
A study testing radiofrequency ablation in people with Varicose Veins, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 5 sitesChina
- Study dates
- 24 Mar 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 322000
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
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
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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- radiofrequency ablation
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationDevice
ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients
| Study group | Role | What they receive |
|---|---|---|
| Endovenous Radiofrequency Ablation Closure System | Experimental | Not described Receives: Device: radiofrequency ablation |
| ClosureFast™ Radiofrequency Ablation System | Active comparator | Not described Receives: Device: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
Technical success rate
The device is delivered in place and withdrawn smoothly, and the target diseased blood vessel is immediately examined by ultrasound without blood flow.
Measured: 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)
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start24 Mar 2021
- Primary completion1 Jan 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671641
- Sponsor's protocol ID
- RFS 1.0
- Status last verified
- Jun 2025
- First submitted
- 10 Dec 2020
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04671641
- Acronym / sponsor ID
- RFS 1.0
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTDIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovenous Radiofrequency Ablation Closure System | Experimental | Device: radiofrequency ablation |
| ClosureFast™ Radiofrequency Ablation System | Active comparator | Device: radiofrequency ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationultrasound-guided radiofrequency ablation is performed to treat varicose veins patients | Device | ClosureFast™ Radiofrequency Ablation System, Endovenous Radiofrequency Ablation Closure System |
Primary outcome
Vascular closure rate at 6 months after the operation
Time frame: 6 months
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.
4 secondary outcomes
CEAP
Time frame: 6 months
Technical success rate
Time frame: 6 months
Evaluation of the use of devices
Time frame: 6 months
VCSS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation in people with Varicose Veins, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular closure rate at 6 months after the operation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.