An interventional study of Medical Adhesive and ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter in Varicose Veins of Lower Limb, sponsored by Peking University People's Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.
This study's enrollment of 188 is above the median of 104 across 162 interventional studies indexed under Varicose Veins.
Browse Varicose Veins studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Medical Adhesive
Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter
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 (produced by America Medtronic Inc.) The ClosureFast catheter precisely heats a 7 cm vein segment in one 20-second interval.
Clinical success rate
At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
Time frame: 24 weeks after operation.
Technical success rate
Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels.
Time frame: Immediately after operation
Target vascular closure rate at 12 weeks after operation.
At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
Time frame: 12 weeks after operation.
Clinical signs
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
Time frame: Screening period, 12 and 24 weeks after operation.
Venous Clinical Severity Score (VCSS)
The VCSS score ranges from 0 to 30, with a larger value indicating approximately severe symptoms.
Time frame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Aberdeen Varicose Vein Questionnaire (AVVQ)
AVVQ scores range between 0 and 33, a higher score indicates a lower quality of life for patients.
Time frame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Operation duration
Time frame: Immediately after operation
Evaluation of product performance
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.
Time frame: within 24 hours after operation
Plan to share: No
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital