Varicose VeinsNCT07827339
Non-Inferiority Clinical Evaluation of a Novel Varicose Vein Closure Adhesive System for Lower Extremity Varicose Veins
A study testing CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) and RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) in people with Varicose Veins, run by Shanghai TENDFO Medical Technology Co., Ltd. at 6 sites in China.
Trial summary
A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co., Ltd.) or radiofrequency ablation (RFA). 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?
- CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) and RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 6 sitesChina
- Study dates
- 24 Oct 2023to 18 Apr 2026
- 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 years and ≤ 80 years at the time of screening, no restrictions on gender.
- Clinical diagnosis of unilateral / bilateral varicose GSV of lower extremities. This operation only deals with unilateral trunk of GSV.
- CEAP classification of C2 - C4b.
- Ability to understand the requirements of the study, provide informed consent, and attend follow-up visits.
Who cannot join
- Life expectancy <1 year.
- Patients with vessel diameter < 3mm or > 12mm in the target segment of the GSV.
- Deep vein thrombosis (DVT) (excluding intermuscular venous thrombosis) or pulmonary embolism (PE).
- Undergone interventional or surgical treatment of the GSV in the target limb.
- Allergies to lidocaine or cyanoacrylates.
- GSV was extreme distorted and thus unsuitable for minimally invasive interventional treatment.
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- Aneurysm of the target vein with local vein diameter >12 mm.
- Active superficial thrombophlebitis in the target GSV.
- Pregnant and / or lactating patients.
- Patients who are participating in clinical trials of other drugs or medical devices.
- Patients considered ineligible for inclusion by the investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Jinhua, Zhejiang, 322000
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Ruian People's Hospital
Ruian, Zhejiang, 325200
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of a Novel Varicose Vein Closure Adhesive System for the Treatment of Lower Extremity Varicose Veins
A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co., Ltd.) or radiofrequency ablation (RFA).
Read the detailed description
This prospective, multicenter, randomized, controlled, non-inferiority trial will enroll 180 patients with great saphenous vein (GSV) varicosities across multiple qualified centers. Eligible patients who provide informed consent will be randomized 1:1 to receive either the experimental treatment with cyanoacrylate closure (CAC) ( the Varicose Vein Closure Adhesive System, Shanghai Tendfo Medical Technology Co., Ltd.) or the control treatment with radiofrequency ablation (RFA) (the ClosureRFG™ generator and ClosureFast™ catheter, Medtronic Inc.), resulting in 90 patients per group. Enrollment is expected to start in June 2023 and complete by the end of 2023. Follow-up visits will occur before discharge or at 7 days after surgery, and at months 1, 3, 6, and 12, with Doppler ultrasound assessments at months 1, 3, 6, and 12 after surgery.
- Conditions
- Varicose Veins
- Being tested
- CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.), RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)Device
Endovenous delivery of adhesive to the target site in diseased GSV by a tube. Deliver the adhesive in segmental fashion, until the target vein was completely closed.
RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)Device
Endovenous insertion of the ClosureFast RFA catheter into a target site in diseased GSV. Heat is applied to the target vein using radiofrequency energy released by the ClosureRFG™ to ablate the target vein.
| Study group | Role | What they receive |
|---|---|---|
| CAC | Experimental | Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) Receives: Device: CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) |
| RFA | Active comparator | the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) Receives: Device: RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of participants with complete GSV closure
Complete closure was defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm in length.
Measured: 3 months after surgery
Secondary outcomes (9)
The rate of participants with complete GSV closure
Complete closure was defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm in length.
Measured: 1、6、12 months after surgery
Success rate of operation
Immediately after the operation, an ultrasound examination showed that the GSV had been closed.
Measured: Immediately after surgery
Pain score
After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.
Measured: Before discharge or 7 days after surgery
Performance evaluation of the novel vein closure system
The handling performance of the investigational device in the experimental group, comprising introducibility, accuracy, convenience, and compatibility, shall be evaluated by the investigator.
Measured: During or after surgery
Ecchymosis evaluation
The investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis.
The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site.
The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria:
0 rating = no ecchymosis,
- rating = less than 25% ecchymosis,
- rating = 25-50% ecchymosis,
- rating = 50-75% ecchymosis,
- rating = 75-100% ecchymosis,
- rating = extension of ecchymosis above or below the treated area.
Measured: Before discharge or 7 days after surgery
CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification
CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification is employed to characterize patients with chronic venous disorders. The clinical manifestations (C) are graded by the investigator based on clinical signs and symptoms of patients.
Measured: Screening period and 1、3、6、12 months after surgery
Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30.
Measured: Screening period and 1、3、6、12 months after surgery
Aberdeen Varicose Vein Questionnaire (AVVQ)
The Aberdeen Varicose Vein questionnaire (AVVQ) with 12-question survey was used to determine the quality of life of patients with varicose veins both before and after surgery (0=best quality of life; 100=worse quality of life).
Measured: Screening period and 1、3、6、12 months after surgery
AE rates
Adverse events and serious adverse events, including deep vein thrombosis (DVT), clinically symptomatic pulmonary embolism (PE), sensory abnormalities, epidermal numbness (nerve injury), skin burns, skin ulcers, and infections/cellular tissue inflammation, etc.
Measured: The day of surgery, before discharge, 7 days, 1 month, 3 months, 6 months and 12 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 posted18 Sep 2026
- Study start24 Oct 2023
- Primary completion4 Dec 2024
- Study completion18 Apr 2026
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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai TENDFO Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827339
- Sponsor's protocol ID
- TF19-029A
- Status last verified
- Jul 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of a Novel Varicose Vein Closure Adhesive System for the Treatment of Lower Extremity Varicose Veins
- ClinicalTrials.gov ID
- NCT07827339
- Acronym / sponsor ID
- TF19-029A
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Shanghai TENDFO Medical Technology Co., Ltd.University, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 18 Apr 2026 (actual)
- First posted
- 18 Sep 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.
A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co., Ltd.) or radiofrequency ablation (RFA).
Detailed description
This prospective, multicenter, randomized, controlled, non-inferiority trial will enroll 180 patients with great saphenous vein (GSV) varicosities across multiple qualified centers. Eligible patients who provide informed consent will be randomized 1:1 to receive either the experimental treatment with cyanoacrylate closure (CAC) ( the Varicose Vein Closure Adhesive System, Shanghai Tendfo Medical Technology Co., Ltd.) or the control treatment with radiofrequency ablation (RFA) (the ClosureRFG™ generator and ClosureFast™ catheter, Medtronic Inc.), resulting in 90 patients per group. Enrollment is expected to start in June 2023 and complete by the end of 2023. Follow-up visits will occur before discharge or at 7 days after surgery, and at months 1, 3, 6, and 12, with Doppler ultrasound assessments at months 1, 3, 6, and 12 after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAC | Experimental | Device: CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) |
| RFA | Active comparator | Device: RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤ 80 years at the time of screening, no restrictions on gender.
- Clinical diagnosis of unilateral / bilateral varicose GSV of lower extremities. This operation only deals with unilateral trunk of GSV.
- CEAP classification of C2 - C4b.
- Ability to understand the requirements of the study, provide informed consent, and attend follow-up visits.
Key exclusion criteria (11 listed)
- Life expectancy <1 year.
- Patients with vessel diameter < 3mm or > 12mm in the target segment of the GSV.
- Deep vein thrombosis (DVT) (excluding intermuscular venous thrombosis) or pulmonary embolism (PE).
- Undergone interventional or surgical treatment of the GSV in the target limb.
- Allergies to lidocaine or cyanoacrylates.
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 |
|---|---|---|
| CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)Endovenous delivery of adhesive to the target site in diseased GSV by a tube. Deliver the adhesive in segmental fashion, until the target vein was completely closed. | Device | CAC |
| RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)Endovenous insertion of the ClosureFast RFA catheter into a target site in diseased GSV. Heat is applied to the target vein using radiofrequency energy released by the ClosureRFG™ to ablate the target vein. | Device | RFA |
Primary outcome
The rate of participants with complete GSV closure
Time frame: 3 months after surgery
Complete closure was defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm in length.
9 secondary outcomes
The rate of participants with complete GSV closure
Time frame: 1、6、12 months after surgery
Success rate of operation
Time frame: Immediately after surgery
Pain score
Time frame: Before discharge or 7 days after surgery
Performance evaluation of the novel vein closure system
Time frame: During or after surgery
Ecchymosis evaluation
Time frame: Before discharge or 7 days after surgery
CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification
Time frame: Screening period and 1、3、6、12 months after surgery
Venous Clinical Severity Score (VCSS)
Time frame: Screening period and 1、3、6、12 months after surgery
Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: Screening period and 1、3、6、12 months after surgery
AE rates
Time frame: The day of surgery, before discharge, 7 days, 1 month, 3 months, 6 months and 12 months after surgery
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 18 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) and RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) in people with Varicose Veins, run by Shanghai TENDFO Medical Technology Co., Ltd. at 6 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 4 inclusion and 11 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The rate of participants with complete GSV closure (time frame: 3 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 18 Sep 2026.