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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Adhesive treatment group | Experimental |
| |
| Endovenous Radiofrequency Ablation Catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success rate | At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels. | 24 weeks after operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels. | Immediately after operation |
| Target vascular closure rate at 12 weeks after operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27126643 | Background | Balint R, Farics A, Parti K, Vizsy L, Batorfi J, Menyhei G, Balint IB. Which endovenous ablation method does offer a better long-term technical success in the treatment of the incompetent great saphenous vein? Review. Vascular. 2016 Dec;24(6):649-657. doi: 10.1177/1708538116648035. Epub 2016 Apr 28. | |
| 25650040 | Background |
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| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Liaocheng People's Hospital | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
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| 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. |
|
At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
| 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 | 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. | 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. | Screening period, 4 weeks, 12 weeks and 24 weeks after operation. |
| Operation duration | 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. | within 24 hours after operation |
| Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31. |
| 28411697 | Background | Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6. |
| 32577526 | Background | Dimech AP, Cassar K. Efficacy of Cyanoacrylate Glue Ablation of Primary Truncal Varicose Veins Compared to Existing Endovenous Techniques: A Systematic Review of the Literature. Surg J (N Y). 2020 Jun 19;6(2):e77-e86. doi: 10.1055/s-0040-1708866. eCollection 2020 Apr. |
| 29229466 | Background | Beteli CB, Rossi FH, de Almeida BL, Izukawa NM, Onofre Rossi CB, Gabriel SA, Kambara AM, de Moraes Rego Sousa AG, Thorpe P. Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):212-219. doi: 10.1016/j.jvsv.2017.09.010. Epub 2017 Dec 9. |
| 21934487 | Background | Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a. |