Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

NCT06711120 | Recruiting

• 1 other identifier: ChengduUTCMvs8
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.

Conditions

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

Keywords

varicose veins of the small saphenous veins; radiofrequency ablation; microwave ablation

Outcome Measures

Primary Outcomes (1)

• 6-month postoperative occlusion rate

  occlusion defined as no flow recirculation of the closed treated segment of the vein as confirmed by Doppler ultrasound

  6 months after surgery

Study Arms (2)

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.

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.

Procedure: Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively

Interventions

Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively PROCEDURE

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.

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

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;
• 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;
• Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Chunshui He, Doctor

CONTACT

86-18981885601; Chunshuihe@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)