Observing pain during microwave treatment for varicose veins
Official title: Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation, and Analysis of Related Factors
Run by Chengdu University of Traditional Chinese Medicine · NCT06693245 · Data updated 2026-11-12
This study looks at how much pain patients feel during microwave treatment for varicose veins to see if different factors like age and weight affect their experience, with the goal of making the procedure more comfortable.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 155 (estimated) |
| Sponsor | Chengdu University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT06693245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 90 with primary varicose veins requiring treatment of the great saphenous vein.
✕Probably not a fit
Patients with a history of deep vein thrombosis or those who have had previous varicose vein surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess pain levels experienced by patients undergoing microwave ablation for great saphenous vein varicosities at various stages of the procedure. It records pain scores at four key time points during surgery and analyzes how factors such as age, gender, and body mass index correlate with intraoperative pain. The goal is to identify ways to improve surgical techniques and reduce pain for patients undergoing this treatment. By focusing on the patient's experience, the study seeks to enhance the overall quality of care in vascular surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies during microwave ablation, enhancing patient comfort and satisfaction.
How similar studies have gone: While there is limited research specifically on intraoperative pain during microwave ablation, studies on pain management in similar vascular procedures have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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;
Where it's running
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Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China Recruiting
Study contacts
- Study coordinator: Chunshui He, Doctor
- Email: Chunshuihe@msn.com
- Phone: 86-18981885601
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.