Compont - Varicose Veins of the Lower Extremities
- Conditions
- Varicose Veins of Lower Limb
- Interventions
- Device: Medical AdhesiveDevice: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter
- Registration Number
- NCT06387264
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 188
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medical Adhesive treatment group Medical Adhesive - Endovenous Radiofrequency Ablation Catheter ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter -
- Primary Outcome Measures
Name Time Method Clinical success rate 24 weeks after operation. At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
- Secondary Outcome Measures
Name Time Method Target vascular closure rate at 12 weeks after operation. 12 weeks after operation. At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
Operation duration Immediately after operation Venous Clinical Severity Score (VCSS) 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.
Technical success rate Immediately after operation Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels.
Clinical signs 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 ulcerAberdeen Varicose Vein Questionnaire (AVVQ) 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.
Evaluation of product performance 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.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, China