An interventional study of CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) and RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) in Varicose Veins, sponsored by Shanghai TENDFO Medical Technology Co., Ltd.. Completed at 6 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Shanghai TENDFO Medical Technology Co., Ltd. · Not applicable, Interventional, and Treatment
Among 23 studies in Varicose Veins with a site in China — 7 open to participants now, 11 under way, none of them phase 3. Varicose Veins · China.
Among the 23 studies in Varicose Veins with a site in China, this one is the 8th largest by enrollment of the 13 interventional ones that give a count, is one of 7 that started in 2023, is one of 13 with no phase, and was the 23rd registered.
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
Browse Varicose Veins studies →7 of the 23 studies in Varicose Veins with a site in China are open now. Recruiting first, the newest first:
Second Affiliated Hospital of Nanchang University · Sites in China
Beijing 302 Hospital · Sites in China
Chengdu University of Traditional Chinese Medicine · Sites in China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Sites in China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 22 Varicose Veins studies recruiting now, 12 (55%) set no upper age limit and 4 (18%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 7 started in 2023.
This study's enrollment of 179 is above the median of 101 across 154 interventional studies indexed under Varicose Veins.
Median enrollment 180 across the 13 interventional studies, 746 across the 10 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 23 have an industry lead sponsor. The 10 most frequent:
Shanghai TENDFO Medical Technology Co., Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Shanghai TENDFO Medical Technology Co., Ltd. has 1 study filed under Varicose Veins — fewer than ten, so there is no comparison to draw.
2 of the studies in Varicose Veins with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07445425Sir Run Run Shaw HospitalComparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins | 2026-12 |
| NCT07907315Chunshui HePain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave | 2027-01-31 |
Among the 23 studies in Varicose Veins with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)
Device: CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)
the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
Device: RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
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.
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.
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.
Time frame: 3 months after surgery
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.
Time frame: 1、6、12 months after surgery
Success rate of operation
Immediately after the operation, an ultrasound examination showed that the GSV had been closed.
Time frame: 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.
Time frame: 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.
Time frame: 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, 1. rating = less than 25% ecchymosis, 2. rating = 25-50% ecchymosis, 3. rating = 50-75% ecchymosis, 4. rating = 75-100% ecchymosis, 5. rating = extension of ecchymosis above or below the treated area.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: The day of surgery, before discharge, 7 days, 1 month, 3 months, 6 months and 12 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Dec 2024, 13 months.
Of 62 non-industry interventional studies with no phase under Varicose Veins, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 13 months is below that.
Counting every sponsor, half of 72 studies reached it within 22 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shanghai TENDFO Medical Technology Co., Ltd.