Vascular Diseases, PeripheralEMINENCENCT04645771
Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins
A study testing Questionnaires in people with Vascular Diseases, Peripheral and Venous Insufficiency of Leg, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vascular Diseases, Peripheral, Venous Insufficiency of Leg, Varicose Veins of Lower Limb
- What is being tested?
- Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2021to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610000
Ye Gao, Master, 18883367703, 18883367703@163.com
About this study
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.
Read the detailed description
The chronic venous insufficiency of lower extremities (chronic venous insufficiency, CVI) is a set of a series of clinical syndrome caused by venous reflux, common symptoms are heaviness, fatigue, swelling, burning sentation, itching, pain, etc.The main causes of superficial varicose veins are weakness of superficial vein wall, insufficiency or defect of vein valve closure and increased pressure inside veins.The weakness of venous wall, the decreasing of flexibility, venous valve defects the the poor structure, be related with genetic factor, belong to "primary" inferior venous valves' incomplete closure.The influencing factors of primary valve insufficiency include heavy physical labor, long standing or sitting work, obesity, pregnancy, chronic constipation, and chronic cough.Varicose veins secondary to a history of venous thrombosis of the lower extremities, venous system obstruction and increased venous pressure caused by circulating blood volume exceeding reflux load are secondary.When the valve of the great saphenous vein at the junction of the saphenous vein is damaged and closed incompletely, the valve function of the distal and perforating vein can be affected step by step, and the small saphenous vein can also be affected through its branch vein.Because the superficial vein wall's muscle layer is thin and their surrounding lackness of connective tissue, blood regurgitation can cause the venous lumen to thicken, tortuosity and lengthen, presenting as superficial varicose veins.Because of the severe venous pressure of lower extremity,the vascular permeability of football boots is increasing,resulting the appearance of a large number of blood capillary hyperplasia.Due to a large number of fibrinogen hindered the exchange between capillary and the surrounding tissue, the nutritional change of subcutaneous tissue occured,including skin pigmentation, eczema, dermatitis, subcutaneous lipid sclerosis and ulceration.
The traditional treatments of lower extremity varicose veins,including high ligation and stripping of great saphenous vein,varicose vein's resection and ligation of perforating vein,can cause large trauma,huge pain,limitation of activity and long convalescence and aesthetic problems,etc.As a consequence,a variety of minimally invasive method with small wound,little pain and early recovery are prevalently applied in clinical, also achieved plenty of good therapeutic effect.According to the different mechanism of minimally invasive treatment, it can be divided into two categories: physical injury (laser closure, radiofrequency closure, microwave treatment, electrocoagulation, transparent direct rotation, laparoscopic great saphenous vein resection, etc.) and chemical injury (sclerosing agent injection).
Clinical observation in our department found that the pain, bruising, numbness, and number of incisions after microwave ablation were all lower than those of traditional high position ligation and extraction with laser closure.
The purpose of this study is to report a monocentricity, prospective Chinese experience using the ECO Varicose Veins Therapeutic Unit from ECO (Nanjing ECO Microwave System Co.Ltd) for Endovenous Microwave Ablation (EMA) to treat primary great and short saphenous vein reflux and to evaluate its safety, efficacy and life quality.
- Being tested
- Questionnaires
- Keywords
- microwave ablation, varicose veins, traditional treatment
- Medical subject headings
- Peripheral Vascular Diseases, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesProcedure or surgery
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately post-procedure
Anatomical Success
Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel
Measured: 3days
Anatomical Success
Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel
Measured: 12 months post-procedure
Secondary outcomes (7)
Instrumental success
successful delivery of endovenous microwave ablation catheter in right place and successful withdrawal after microwave treatment is defined as Instrumental success
Measured: Immediately post-procedure
Quality of Life score using EQ-5D questionnaire
EQ-5D is used to assess quality of life based on Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe the changes in quality of life over the whole test procedure
Measured: Baseline, 1 month, 6 months and 12 months
Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe).Based on inputs, CIVIQ-14 will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.In order to observe the changes in quality of life over the whole test procedure.
Measured: Baseline, 1 month, 6 months and 12 months
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
To measure health status of varicose vein participants based on symptoms and impact on daily activities. A total score ranging from 0 to 30 will be tabulated, with 30 being worst quality of life.In order to observe the changes in quality of life over the whole test procedure.
Measured: Baseline, 1 month, 6 months and 12 months
Clinical Change using Venous Clinical Severity Score (VCSS)
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).Record the score separately to observe the changes in quality of life over the whole test procedure.
Measured: Baseline, 1 month, 6 months and 12 months
Time taken to return to work and normal activities
Investigators will make a call to follow up the day when the participants return to work and normal activities
Measured: 10 days post-op
Participants' satisfaction post-procedure
To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied) through an app named Recovery+
Measured: 3 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start4 Feb 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vascular Diseases, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645771
- Sponsor's protocol ID
- ChengduUTCMvs
- Acronym
- EMINENCE
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21536172Yang 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.
PubMed 32792099Yang 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.
PubMed 23911734Liu 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.
PubMed 31260115Brace 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.
PubMed 19179193Proebstle 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.
PubMed 18178468Quehe 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.
PubMed 30891243Lawson 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.
PubMed 29248107Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.
PubMed 16227498Vogl 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.
PubMed 19700254Zhang 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.
PubMed 39183572
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins
- ClinicalTrials.gov ID
- NCT04645771
- Acronym / sponsor ID
- EMINENCE / ChengduUTCMvs
- Keywords
- microwave ablation, varicose veins, traditional treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The chronic venous insufficiency of lower extremities (chronic venous insufficiency, CVI) is a set of a series of clinical syndrome caused by venous reflux, common symptoms are heaviness, fatigue, swelling, burning sentation, itching, pain, etc.The main causes of superficial varicose veins are weakness of superficial vein wall, insufficiency or defect of vein valve closure and increased pressure inside veins.The weakness of venous wall, the decreasing of flexibility, venous valve defects the the poor structure, be related with genetic factor, belong to "primary" inferior venous valves' incomplete closure.The influencing factors of primary valve insufficiency include heavy physical labor, long standing or sitting work, obesity, pregnancy, chronic constipation, and chronic cough.Varicose veins secondary to a history of venous thrombosis of the lower extremities, venous system obstruction and increased venous pressure caused by circulating blood volume exceeding reflux load are secondary.When the valve of the great saphenous vein at the junction of the saphenous vein is damaged and closed incompletely, the valve function of the distal and perforating vein can be affected step by step, and the small saphenous vein can also be affected through its branch vein.Because the superficial vein wall's muscle layer is thin and their surrounding lackness of connective tissue, blood regurgitation can cause the venous lumen to thicken, tortuosity and lengthen, presenting as superficial varicose veins.Because of the severe venous pressure of lower extremity,the vascular permeability of football boots is increasing,resulting the appearance of a large number of blood capillary hyperplasia.Due to a large number of fibrinogen hindered the exchange between capillary and the surrounding tissue, the nutritional change of subcutaneous tissue occured,including skin pigmentation, eczema, dermatitis, subcutaneous lipid sclerosis and ulceration.
The traditional treatments of lower extremity varicose veins,including high ligation and stripping of great saphenous vein,varicose vein's resection and ligation of perforating vein,can cause large trauma,huge pain,limitation of activity and long convalescence and aesthetic problems,etc.As a consequence,a variety of minimally invasive method with small wound,little pain and early recovery are prevalently applied in clinical, also achieved plenty of good therapeutic effect.According to the different mechanism of minimally invasive treatment, it can be divided into two categories: physical injury (laser closure, radiofrequency closure, microwave treatment, electrocoagulation, transparent direct rotation, laparoscopic great saphenous vein resection, etc.) and chemical injury (sclerosing agent injection).
Clinical observation in our department found that the pain, bruising, numbness, and number of incisions after microwave ablation were all lower than those of traditional high position ligation and extraction with laser closure.
The purpose of this study is to report a monocentricity, prospective Chinese experience using the ECO Varicose Veins Therapeutic Unit from ECO (Nanjing ECO Microwave System Co.Ltd) for Endovenous Microwave Ablation (EMA) to treat primary great and short saphenous vein reflux and to evaluate its safety, efficacy and life quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microwave ablations | Experimental | Procedure: QuestionnairesA 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey) | Procedure or surgery | Microwave ablations |
Primary outcome
Technical Success at time of procedure
Time frame: Immediately post-procedure
Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure
Anatomical Success
Time frame: 3days
Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel
Anatomical Success
Time frame: 12 months post-procedure
Use duplex ultrasound verify the occlusion of treated vessel and record the rate of occlusion of treated vessel
7 secondary outcomes
Instrumental success
Time frame: Immediately post-procedure
Quality of Life score using EQ-5D questionnaire
Time frame: Baseline, 1 month, 6 months and 12 months
Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)
Time frame: Baseline, 1 month, 6 months and 12 months
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
Time frame: Baseline, 1 month, 6 months and 12 months
Clinical Change using Venous Clinical Severity Score (VCSS)
Time frame: Baseline, 1 month, 6 months and 12 months
Time taken to return to work and normal activities
Time frame: 10 days post-op
Participants' satisfaction post-procedure
Time frame: 3 days post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Results publication: PubMed 21536172Gloviczki 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.
- Results publication: PubMed 32792099Yang 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.
- Results publication: PubMed 23911734Yang 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.
- Results publication: PubMed 31260115Liu 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.
- Results publication: PubMed 19179193Brace 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.
- Results publication: PubMed 18178468Proebstle 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.
- Results publication: PubMed 30891243Quehe 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.
- Results publication: PubMed 29248107Lawson 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.
- Results publication: PubMed 16227498Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.
- Results publication: PubMed 19700254Vogl 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.
- Derived from this study: PubMed 39183572Zhang 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.
- Individual participant dataSharing planned: No
Related trials for Vascular Diseases, Peripheral
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Vascular Diseases, Peripheral and Venous Insufficiency of Leg, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He, Doctor (18981885601, chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success at time of procedure (time frame: Immediately post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645771, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.