Varicose Veins of Lower LimbNCT07445425
Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins
A study testing Staged surgery group and Concomitant surgery group in people with Varicose Veins of Lower Limb, run by Sir Run Run Shaw Hospital at 21 sites in China.
Trial summary
The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are: Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Staged surgery group and Concomitant surgery group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 21 sitesChina
- Study dates
- Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.
Who cannot join
- Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) <0.6 and/or absolute ankle pressure <60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter>3.5mm; any other patients investigator considers improper to participate in this study.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites
Peking University International Hospital
Beijing, Beijing Municipality
Qian Wang
Peking University Third Hospital
Beijing, Beijing Municipality
Changming Wang
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Zhaowen Yu, 8613309651876
The First People's Hospital of Chenzhou
Chenzhou, Hunan
Yide Zheng
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Ming Qi, 8618098875991
Dezhou People's Hospital
Dezhou, Shandong
Haiqing Wang, 8613053420366
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan
Chuang Wang, 8613514808066
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Meijia Xu, Postgraduate, +8619700777750, 1341506760@qq.com
Yuefeng Zhu
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
Luyang Meng, 13777831991
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhenjie Liu
Huai'an First People's Hospital
Huai'an, Jiangsu
Gang Xu, 8618851258521
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Weimin Zhou, 8613870658585
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu
Weihua Jiang, 8613770662060
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi
Lei Yu, 8613387719938
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi
Yaochang Luo, 8615907713918
Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Jian Zhang
Yantai Yuhuangding Hospital
Yantai, Shandong
Lubin Li, 8618653587355
Zhengzhou Central Hospital
Zhengzhou, Henan
Bin Song
Zhoukou Central Hospital
Zhoukou, Henan
Xianwei Qi
Zibo First Hospital
Zibo, Shandong
Tong Liu, 8613156987626
About this study
Official title: Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study
The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are:
Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies?
Participants will:
Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination.
Record their symptoms
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Staged surgery group, Concomitant surgery group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged surgery groupProcedure or surgery
The patient is placed in the supine position, and then a DUS examination of the GSV in the affected limbs will be performed. At the appropriate site, local anesthesia will be performed, and the ultrasound-guided Seldinger technique will be used to puncture the main trunk of the GSV 10cm above and below the knee joint. When the needle puncture is successful, we will insert the guidewire, and a 7F vascular sheath (Terumo) will be inserted along the guidewire. Then, we will insert the radiofrequency catheter and advanced the tip to approximately 2 cm at the junction of the saphenofemoral vein, where it will be left in place. Under ultrasound guidance, the needle will be tightly attached to the GSV sheath, and an anesthetic solution will be injected to treat the swelling until the junction of the saphenofemoral vein will be reached. Then, we will secure the tip of the radiofrequency catheter and switch on the radiofrequency generator and ablated the primary trunk of the GSV in segments.
Concomitant surgery groupProcedure or surgery
While the experimental group receives ablation alone, the control group received 1% polidocanol foam sclerosant injection and/or point excision treatment for the pre-marked calf segment branches of the GSV after ablation treatment. Both groups will wear elastic bandages for 24 hours postoperatively, followed by thigh-length class II compression stockings for 1 week after bandage removal.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: Staged surgery group |
| B | Placebo comparator | Not described Receives: Procedure: Concomitant surgery group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The re-intervention rate
Measured: 1 week, 3 months and 6 months after surgery
Secondary outcomes (12)
Treatment cost
According to the statistics of hospital charging system
Measured: 6 months after surgery
Success rate of varicose vein closure
Measured: 1 week, 3 months and 6 months after surgery
Operation time
Measured: During the operation
Number of incisions
Measured: During the operation
Tumescent anesthesia solution dosage
Measured: During the operation
The amount of intraoperative bleeding
Measured: During the operation
AVVQ score
The Aberdeen varicose vein questionnaire. The score range is 0-100, and the higher the score, the worse the result.
Measured: Before surgery, 1 week, 3 months and 6 months after surgery
VAS score
Visual analogue scale. The score range is 0-10, and the higher the score, the worse the result.
Measured: Before surgery, 1 week, 3 months and 6 months after surgery
VCSS score
Venous clinical severity score. The score range is 0-30, and the higher the score, the worse the result.
Measured: Before surgery, 1 week, 3 months and 6 months after surgery
Postoperative complications
Measured: 1 week, 3 months and 6 months after surgery
Time to return to regular work
Measured: 1 week after surgery
Patient satisfaction
Include two question: "The quality of treatment that you received was good?" "The treatment that you received fulfilled your expectations?"
Measured: During the operation and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445425
- Sponsor's protocol ID
- 2025-2700-01
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07445425
- Acronym / sponsor ID
- 2025-2700-01
- Conditions
- Varicose Veins of Lower Limb
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (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 purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are:
Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies?
Participants will:
Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination.
Record their symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Staged surgery group |
| B | Placebo comparator | Procedure: Concomitant surgery group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.
Key exclusion criteria (1 listed)
- Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) <0.6 and/or absolute ankle pressure <60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter>3.5mm; any other patients investigator considers improper to participate in this study.
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 |
|---|---|---|
| Staged surgery groupThe patient is placed in the supine position, and then a DUS examination of the GSV in the affected limbs will be performed. At the appropriate site, local anesthesia will be performed, and the ultrasound-guided Seldinger technique will be used to puncture the main trunk of the GSV 10cm above and below the knee joint. When the needle puncture is successful, we will insert the guidewire, and a 7F vascular sheath (Terumo) will be inserted along the guidewire. Then, we will insert the radiofrequency catheter and advanced the tip to approximately 2 cm at the junction of the saphenofemoral vein, where it will be left in place. Under ultrasound guidance, the needle will be tightly attached to the GSV sheath, and an anesthetic solution will be injected to treat the swelling until the junction of the saphenofemoral vein will be reached. Then, we will secure the tip of the radiofrequency catheter and switch on the radiofrequency generator and ablated the primary trunk of the GSV in segments. | Procedure or surgery | A |
| Concomitant surgery groupWhile the experimental group receives ablation alone, the control group received 1% polidocanol foam sclerosant injection and/or point excision treatment for the pre-marked calf segment branches of the GSV after ablation treatment. Both groups will wear elastic bandages for 24 hours postoperatively, followed by thigh-length class II compression stockings for 1 week after bandage removal. | Procedure or surgery | B |
Primary outcome
The re-intervention rate
Time frame: 1 week, 3 months and 6 months after surgery
12 secondary outcomes
Treatment cost
Time frame: 6 months after surgery
Success rate of varicose vein closure
Time frame: 1 week, 3 months and 6 months after surgery
Operation time
Time frame: During the operation
Number of incisions
Time frame: During the operation
Tumescent anesthesia solution dosage
Time frame: During the operation
The amount of intraoperative bleeding
Time frame: During the operation
AVVQ score
Time frame: Before surgery, 1 week, 3 months and 6 months after surgery
VAS score
Time frame: Before surgery, 1 week, 3 months and 6 months after surgery
VCSS score
Time frame: Before surgery, 1 week, 3 months and 6 months after surgery
Postoperative complications
Time frame: 1 week, 3 months and 6 months after surgery
Time to return to regular work
Time frame: 1 week after surgery
Patient satisfaction
Time frame: During the operation and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- 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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staged surgery group and Concomitant surgery group in people with Varicose Veins of Lower Limb, run by Sir Run Run Shaw Hospital at 21 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meijia Xu (+8619700777750, 1341506760@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The re-intervention rate (time frame: 1 week, 3 months and 6 months after surgery). 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 3 Mar 2026.