Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins

NCT04645771 | Unknown

• 1 other identifier: ChengduUTCMvs
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of microwave ablation catheter in the treatment of varicose veins in lower extremities,meanwhile, to compare the quality of subjects'lives before and after treatment.

Conditions

Vascular Diseases, Peripheral; Venous Insufficiency of Leg; Varicose Veins of Lower Limb

Keywords

microwave ablation; varicose veins; traditional treatment

Outcome Measures

Primary Outcomes (3)

• Technical Success at time of procedure

  Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure

  Immediately post-procedure

• Anatomical Success

  Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel

  3days

• Anatomical Success

  Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel

  12 months post-procedure

Secondary Outcomes (7)

• Instrumental success

  Immediately post-procedure

• Quality of Life score using EQ-5D questionnaire

  Baseline, 1 month, 6 months and 12 months

• Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)

  Baseline, 1 month, 6 months and 12 months

• Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)

  Baseline, 1 month, 6 months and 12 months

• Clinical Change using Venous Clinical Severity Score (VCSS)

  Baseline, 1 month, 6 months and 12 months

Study Arms (1)

Microwave ablations

EXPERIMENTAL

A total of 50 patients with varicose veins of lower extremities treated with microwave ablation catheter were selected to observe their annual venous closure rate and postoperative adverse reactions.

Procedure: Questionnaires

Interventions

Questionnaires PROCEDURE

Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

Microwave ablations

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age \>18 years, and \<90 years ,and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up.
• C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness,fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
• Patients who has GSV, SSV AASV diameters of 3mm to 12mm in the standing postition.
• Only one limb of each patient was included in the study.

You may not qualify if:

• \- Current DVT or history of DVT. Recurrent varicose veins. Pregnant patients. Arterial disease (ABPI \<0.8). Patients who are unwilling to participate this test. Inability or unwillingness to complete questionnaires. Adverse reaction to sclerosant or cyanoacrylate. GSV, SSV or AASV severely tortuous. Infectious disease. Life expectancy \< 1 year. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin). Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease.
• The investigators determined that intravenous therapy was not appropriate.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (11)

• Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

  PMID: 21536172 RESULT

• Yang L, Wang X, Wei Z, Zhu C, Liu J, Han Y. The clinical outcomes of endovenous microwave and laser ablation for varicose veins: A prospective study. Surgery. 2020 Nov;168(5):909-914. doi: 10.1016/j.surg.2020.06.035. Epub 2020 Aug 10.

  PMID: 32792099 RESULT

• Yang L, Wang XP, Su WJ, Zhang Y, Wang Y. Randomized clinical trial of endovenous microwave ablation combined with high ligation versus conventional surgery for varicose veins. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):473-9. doi: 10.1016/j.ejvs.2013.07.004. Epub 2013 Aug 1.

  PMID: 23911734 RESULT

• Liu D, Brace CL. Evaluation of tissue deformation during radiofrequency and microwave ablation procedures: Influence of output energy delivery. Med Phys. 2019 Sep;46(9):4127-4134. doi: 10.1002/mp.13688. Epub 2019 Jul 17.

  PMID: 31260115 RESULT

• Brace CL. Microwave ablation technology: what every user should know. Curr Probl Diagn Radiol. 2009 Mar-Apr;38(2):61-7. doi: 10.1067/j.cpradiol.2007.08.011.

  PMID: 19179193 RESULT

• Proebstle TM, Vago B, Alm J, Gockeritz O, Lebard C, Pichot O. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience. J Vasc Surg. 2008 Jan;47(1):151-156. doi: 10.1016/j.jvs.2007.08.056.

  PMID: 18178468 RESULT

• Quehe P, Alavi Z, Kurylo-Touz T, Saliou AH, Badra A, Baudino L, Gladu G, Ledan F, Haudebourg R, Gestin S, Bressollette L. Endovenous Celon radiofrequency-induced thermal therapy of great saphenous vein: A retrospective study with a 3-year follow-up. SAGE Open Med. 2018 Aug 21;6:2050312118794591. doi: 10.1177/2050312118794591. eCollection 2018.

  PMID: 30891243 RESULT

• Lawson JA, Gauw SA, van Vlijmen CJ, Pronk P, Gaastra MTW, Tangelder MJ, Mooij MC. Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radiofrequency-powered segmental ablation or 1470-nm endovenous laser ablation with radial-tip fibers (Varico 2 study). J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):31-40. doi: 10.1016/j.jvsv.2017.06.016. Epub 2017 Aug 24.

  PMID: 29248107 RESULT

• Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.

  PMID: 16227498 RESULT

• Vogl TJ, Naguib NN, Lehnert T, Nour-Eldin NE. Radiofrequency, microwave and laser ablation of pulmonary neoplasms: clinical studies and technical considerations--review article. Eur J Radiol. 2011 Feb;77(2):346-57. doi: 10.1016/j.ejrad.2009.07.034. Epub 2009 Aug 22.

  PMID: 19700254 RESULT

• Zhang L, Lin Y, Geng C, Huang W, Yang Q, He C, Zeng W. Safety and efficacy of endovenous microwave ablation for treatment of varicose veins of the lower limbs in China: A prospective registered clinical trial. Vascular. 2025 Oct;33(5):1011-1019. doi: 10.1177/17085381241273225. Epub 2024 Aug 26.

  PMID: 39183572 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Varicose Veins

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Chunshui He, Doctor

CONTACT

18981885601; chunshuihe@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery in ChengduUTCM

Model Details: A total of 50 patients with varicose veins of lower extremities treated with microwave ablation catheter were selected to observe their venous closure rate and postoperative adverse reactions.

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 27, 2020
• Study Start: February 4, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 5, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)