Compont - Varicose Veins of the Lower Extremities

Varicose Veins of Lower Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06387264
• Other study ID #: 2022PHC032
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking University People's Hospital	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

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Technical success rate	Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels.	Immediately after operation
Secondary	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.	12 weeks after operation.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Operation duration		Immediately after operation
Secondary	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