Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors

Launched by CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how much pain patients feel during a specific treatment for varicose veins in the leg, known as microwave ablation. The researchers will monitor pain levels at different stages of the procedure and look for links between pain and factors like age, gender, and the amount of fluid used during the treatment. They hope to use this information to improve the procedure and make it more comfortable for patients.

To participate in this study, patients need to be between 18 and 90 years old and have been diagnosed with primary varicose veins that require treatment. They should also have a specific type of varicose vein that meets certain size and location criteria. Participants can expect to have their pain levels recorded at various points during the treatment, and their feedback will help enhance the surgical process. It's important to note that some individuals won't be eligible, such as those with certain medical conditions or who are currently taking specific medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥ 18 years old, ≤ 90 years old;
• • 2. the patient's life expectancy is greater than 12 months;
• • 3. The clinical diagnosis is primary VVs, CEAP classification C2-C6, and the GSV segment needs to be treated, including pain, burning sensation, heaviness, fatigue, itchy skin, night cramps and other clinical symptoms;
• • 4. Doppler ultrasound confirmed that the diameter of GSV was greater than 3mm and less than 12mm when standing;
• • 5. Doppler ultrasound confirms that GSV is located in the saphenofascia or the distance between GSV and the skin surface is \>1cm;
• • 6. endovenous microwave ablation treatment only for unilateral GSV walking area;
• • 7. The patient is willing to cooperate with the completion of the examination specified in the protocol.
• Exclusion Criteria:
• • 1. GSV thrombosis, or combined with deep vein thrombosis, or previous history of deep vein thrombosis and pulmonary embolism;
• • 2. patients with recurrence after prior VVs-related surgery (C2r);
• • 3. the GSV trunk is severely distorted, and it is expected that the catheter will not be able to pass;
• • 4. Severe ischemia of the lower limbs, Ankle brachial pressure index (ABPI) \< 0.8;
• • 5. Known allergy to the drugs and device materials involved in the study;
• • 6. Previously implanted with a pacemaker or defibrillator, and currently receiving regular anticoagulation therapy (such as warfarin, heparin);
• • 7. Pregnant or lactating females;
• • 8. Patients who are unable or unwilling to participate in the study;
• • 9. Participating in the research of other drugs or devices;
• • 10. Skin malignancies other than non-melanoma that are being treated;
• • 11. daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain caused by venous disease;
• • 12. The investigator judged that endovenous treatment was not suitable;