Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
188 participants
INTERVENTIONAL
2023-01-11
2024-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medical Adhesive treatment group
Medical Adhesive
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.
Endovenous Radiofrequency Ablation Catheter
ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter
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.
Interventions
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Medical Adhesive
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Liaocheng People's Hospital
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Zhang Xiaoming
Chief physician of Vascular Surgery
Locations
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Peking University People's Hospital
Beijing, , China
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2022PHC032
Identifier Type: -
Identifier Source: org_study_id
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