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NCT Number: NCT06387264

Compont - Varicose Veins of the Lower Extremities

The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.

The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.

Participants will:

Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.

Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Varicose Veins of Lower Limb

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
  • CEAP is graded C2-C6.
  • Doppler ultrasound confirmed the patency of deep veins of lower limbs.
  • Sign informed consent, voluntarily participate in the trial and follow up as required

Exclusion criteria

  • A history of lower extremity deep vein thrombosis or pulmonary embolism
  • Recurrent varicose veins
  • The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
  • The great saphenous vein is severely distorted or tuberculated at the root
  • Sepsis or septicemia
  • Allergic to n-butyl cyanoacrylate
  • The distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm
  • Severe cardiopulmonary disease, shock, coma or multiple organ failure
  • Lactating or pregnant women
  • Participated in other clinical trials within 1 month before surgery
  • The researchers considered it unsuitable for inclusion

Treatment and study plan

Medical Adhesive

Device

Medical Adhesive (produced by Beijing Compont Medical Devices Co., Ltd.) For varicose veins in the main saphenous vein, use 0.1 ml glue for every 3 cm of blood vessels.

ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter

Device

ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by America Medtronic Inc.) The ClosureFast catheter precisely heats a 7 cm vein segment in one 20-second interval.

Primary outcomes

  1. Clinical success rate

    Time frame: 24 weeks after operation.

    At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.

Secondary outcomes

  1. Technical success rate

    Time frame: Immediately after operation

    Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels.

  2. Target vascular closure rate at 12 weeks after operation.

    Time frame: 12 weeks after operation.

    At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.

  3. Clinical signs

    Time frame: Screening period, 12 and 24 weeks after operation.

    The severity of the patient's clinical presentation was assessed according to the Clinical signs- etiologic classification- anatomic distribution- pathophysiologic dysfunction classification (CEAP classification) criteria.

    classification are as follows. C0: Without any visible or palpable signs of disease. C1: Telangiectasia or reticular veins C2: Varicose veins C2r: Recurrent varicose veins C3: Edema is present. C4: Changes in skin and subcutaneous tissue C4a: Pigmentation or eczema C4b: Lipodermatosclerosis or atrophie blanche C4c: Corona phlebectatica C5: Healed ulcers C6: Active ulcers C6r: Recurrent active venous ulcer

  4. Venous Clinical Severity Score (VCSS)

    Time frame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.

    The VCSS score ranges from 0 to 30, with a larger value indicating approximately severe symptoms.

  5. Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.

    AVVQ scores range between 0 and 33, a higher score indicates a lower quality of life for patients.

  6. Operation duration

    Time frame: Immediately after operation

  7. Evaluation of product performance

    Time frame: within 24 hours after operation

    The researchers evaluated the operation performance of the product from the aspects of ease of operation and injection function, and divided the evaluation into three levels: satisfactory, general and unsatisfactory.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University
  • Liaocheng People's Hospital
  • Peking University First Hospital
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Chongqing Medical University

Registry information

Official study title

Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Sep 19, 2024

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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