Varicose Veins of Lower LimbNCT06711120
Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins
A study testing Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively in people with Varicose Veins of Lower Limb and Venous Insufficiency of Leg, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Varicose Veins of Lower Limb, Venous Insufficiency of Leg, Vascular Disease，Peripheral
- What is being tested?
- Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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;
- Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
- Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
- Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
- Only one limb per patient was selected for inclusion in the study;
- Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.
Who cannot join
- Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
- Recurrent varicose veins after previous treatment.
- Severe distortion of the great saphenous vein with anticipated catheter failure.
- Severe lower limb ischaemia (CLI) (ABPI <0.8).
- Known allergy to medications and device materials involved in the study.
- Pre-existing implanted pacemaker, defibrillator, currently on regular anticoagulation therapy (e.g., warfarin, heparin).
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- Women who are pregnant or breastfeeding.
- Unable or unwilling to complete the questionnaire.
- Participating in a study of another drug or device.
- Life expectancy <1 year.
- Those undergoing treatment for skin malignancies other than non-melanoma.
- Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain due to venous disease.
- In the judgement of the investigator, endovenous therapy is not appropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu
Chunshui He, Doctor, 86-18981885601, Chunshuihe@msn.com
About this study
Official title: Randomized Controlled Study of Radio Frequency and Microwave of the Small Saphenous Vein
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
Read the detailed description
Chronic venous insufficiency (CVI) is a common clinical disease, and varicose veins of the lower extremities are the main clinical manifestations of CVI, and studies have shown that the prevalence of CVI is 10%~25%.Although small saphenous varicose veins are rare, accounting for only 15% of great saphenous varicose veins, the surgical treatment of small saphenous varicose veins is more challenging due to the small saphenous varicose veins injected into the popliteal vein.In the late 19th and early 20th centuries, high ligation was the only treatment for the small saphenous varicose veins, however, it had a high recurrence rate and increased risk of nerve injury due to the presence of the small saphenous vein with the sural nerve. In open surgery for small saphenous varicose veins, about 26% of patients can be complicated by sural neuropathy, and due to changes in their anatomy, about 22% of patients do not adequately identify the proximal saphenous vein or saphenopopliteal fossa junction intraoperatively, even if the location is determined by ultrasound preoperatively.Since conventional surgery is more traumatic and has more complications, it is not favorable to the patient's postoperative recovery. In recent years, with the development of venous vascular ultrasound imaging technology, ultrasound-guided radiofrequency ablation and microwave ablation have gradually been widely used in the treatment of small saphenous varicose veins. Compared with conventional surgical procedures, radiofrequency ablation and microwave ablation are less invasive, safer and more effective for saphenous varicose veins, but not many studies have been conducted on the safety and efficacy of small saphenous varicose veins. Therefore, the aim of this study was to investigate the clinical efficacy of ultrasound-guided radiofrequency ablation versus microwave ablation in the treatment of primary small saphenous varicose veins.Translated with DeepL.com (free version)
- Being tested
- Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively
- Keywords
- varicose veins of the small saphenous veins, radiofrequency ablation, microwave ablation
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectivelyProcedure or surgery
During the procedure, 2% lidocaine was injected subcutaneously along the course of the saphenous vein under ultrasound guidance, and after local anaesthesia, an incision was made at the ankle joint of the saphenous vein to locate the saphenous vein, and a radiofrequency guidewire and catheter sheath were introduced.The saphenous vein was incised at the ankle joint under local anaesthesia. Under ultrasound monitoring, the radiofrequency catheter was placed in the saphenous popliteal vein at a distance of 1~2 cm and the position of the catheter was fixed, and then anaesthesia and swelling fluid was injected into the fascial tissues around the main trunk of the small saphenous vein in segments.The two groups were treated with radiofrequency ablation and microwave ablation surgery, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation for the treatment of varicose veins of the small saphenous vein | Experimental | After radiofrequency ablation, patients' postoperative length of stay, time out of bed, and visual analogue scoring (VAS) scores were used to count the occurrence of postoperative complications, and all patients were followed up with colour Doppler ultrasound at 2 weeks, 1 month, and 3 months postoperatively to determine whether there was recurrence or not, and the use of the Venous Clinical Criticality Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Chronic Venous Disease Quality of Life Scale (CIVIQ) to evaluate the treatment effect. Receives: Procedure: Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively |
| Microwave ablation for the treatment of varicose veins of the small saphenous vein | Experimental | After Microwave ablation, patients' postoperative length of stay, time out of bed, and visual analogue scoring (VAS) scores were used to count the occurrence of postoperative complications, and all patients were followed up with colour Doppler ultrasound at 2 weeks, 1 month, and 3 months postoperatively to determine whether there was recurrence or not, and the use of the Venous Clinical Criticality Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Chronic Venous Disease Quality of Life Scale (CIVIQ) to evaluate the treatment effect. Receives: Procedure: Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month postoperative occlusion rate
occlusion defined as no flow recirculation of the closed treated segment of the vein as confirmed by Doppler ultrasound
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT06711120
- Sponsor's protocol ID
- ChengduUTCMvs8
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Radio Frequency and Microwave of the Small Saphenous Vein
- ClinicalTrials.gov ID
- NCT06711120
- Acronym / sponsor ID
- ChengduUTCMvs8
- Keywords
- varicose veins of the small saphenous veins, radiofrequency ablation, microwave ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
Detailed description
Chronic venous insufficiency (CVI) is a common clinical disease, and varicose veins of the lower extremities are the main clinical manifestations of CVI, and studies have shown that the prevalence of CVI is 10%~25%.Although small saphenous varicose veins are rare, accounting for only 15% of great saphenous varicose veins, the surgical treatment of small saphenous varicose veins is more challenging due to the small saphenous varicose veins injected into the popliteal vein.In the late 19th and early 20th centuries, high ligation was the only treatment for the small saphenous varicose veins, however, it had a high recurrence rate and increased risk of nerve injury due to the presence of the small saphenous vein with the sural nerve. In open surgery for small saphenous varicose veins, about 26% of patients can be complicated by sural neuropathy, and due to changes in their anatomy, about 22% of patients do not adequately identify the proximal saphenous vein or saphenopopliteal fossa junction intraoperatively, even if the location is determined by ultrasound preoperatively.Since conventional surgery is more traumatic and has more complications, it is not favorable to the patient's postoperative recovery. In recent years, with the development of venous vascular ultrasound imaging technology, ultrasound-guided radiofrequency ablation and microwave ablation have gradually been widely used in the treatment of small saphenous varicose veins. Compared with conventional surgical procedures, radiofrequency ablation and microwave ablation are less invasive, safer and more effective for saphenous varicose veins, but not many studies have been conducted on the safety and efficacy of small saphenous varicose veins. Therefore, the aim of this study was to investigate the clinical efficacy of ultrasound-guided radiofrequency ablation versus microwave ablation in the treatment of primary small saphenous varicose veins.Translated with DeepL.com (free version)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation for the treatment of varicose veins of the small saphenous vein | Experimental | Procedure: Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectivelyAfter radiofrequency ablation, patients' postoperative length of stay, time out of bed, and visual analogue scoring (VAS) scores were used to count the occurrence of postoperative complications, and all patients were followed up with colour Doppler ultrasound at 2 weeks, 1 month, and 3 months postoperatively to determine whether there was recurrence or not, and the use of the Venous Clinical Criticality Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Chronic Venous Disease Quality of Life Scale (CIVIQ) to evaluate the treatment effect. |
| Microwave ablation for the treatment of varicose veins of the small saphenous vein | Experimental | Procedure: Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectivelyAfter Microwave ablation, patients' postoperative length of stay, time out of bed, and visual analogue scoring (VAS) scores were used to count the occurrence of postoperative complications, and all patients were followed up with colour Doppler ultrasound at 2 weeks, 1 month, and 3 months postoperatively to determine whether there was recurrence or not, and the use of the Venous Clinical Criticality Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Chronic Venous Disease Quality of Life Scale (CIVIQ) to evaluate the treatment effect. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and ≤90 years;
- Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
- Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
- Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
- Only one limb per patient was selected for inclusion in the study;
Key exclusion criteria (13 listed)
- Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
- Recurrent varicose veins after previous treatment.
- Severe distortion of the great saphenous vein with anticipated catheter failure.
- Severe lower limb ischaemia (CLI) (ABPI <0.8).
- Known allergy to medications and device materials involved in the study.
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 |
|---|---|---|
| Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectivelyDuring the procedure, 2% lidocaine was injected subcutaneously along the course of the saphenous vein under ultrasound guidance, and after local anaesthesia, an incision was made at the ankle joint of the saphenous vein to locate the saphenous vein, and a radiofrequency guidewire and catheter sheath were introduced.The saphenous vein was incised at the ankle joint under local anaesthesia. Under ultrasound monitoring, the radiofrequency catheter was placed in the saphenous popliteal vein at a distance of 1~2 cm and the position of the catheter was fixed, and then anaesthesia and swelling fluid was injected into the fascial tissues around the main trunk of the small saphenous vein in segments.The two groups were treated with radiofrequency ablation and microwave ablation surgery, respectively. | Procedure or surgery | Microwave ablation for the treatment of varicose veins of the small saphenous vein, Radiofrequency ablation for the treatment of varicose veins of the small saphenous vein |
Primary outcome
6-month postoperative occlusion rate
Time frame: 6 months after surgery
occlusion defined as no flow recirculation of the closed treated segment of the vein as confirmed by Doppler ultrasound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively in people with Varicose Veins of Lower Limb 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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He, Doctor (86-18981885601, Chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month postoperative occlusion rate (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.