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NCT Number: NCT07827339

Non-Inferiority Clinical Evaluation of a Novel Varicose Vein Closure Adhesive System for 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).

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suzhou Municipal Hospital, Suzhou, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The rate of participants with complete GSV closure

    Time frame: 1、6、12 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.

  2. Success rate of operation

    Time frame: Immediately after surgery

    Immediately after the operation, an ultrasound examination showed that the GSV had been closed.

  3. Pain score

    Time frame: Before discharge or 7 days after surgery

    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.

  4. Performance evaluation of the novel vein closure system

    Time frame: During or after surgery

    The handling performance of the investigational device in the experimental group, comprising introducibility, accuracy, convenience, and compatibility, shall be evaluated by the investigator.

  5. Ecchymosis evaluation

    Time frame: Before discharge or 7 days after surgery

    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.

  6. CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification

    Time frame: Screening period and 1、3、6、12 months after surgery

    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.

  7. Venous Clinical Severity Score (VCSS)

    Time frame: Screening period and 1、3、6、12 months after surgery

    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.

  8. Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: Screening period and 1、3、6、12 months after surgery

    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).

  9. AE rates

    Time frame: The day of surgery, before discharge, 7 days, 1 month, 3 months, 6 months and 12 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Shanghai TENDFO Medical Technology Co., Ltd.

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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