NCT06693245 Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors
| NCT ID | NCT06693245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chengdu University of Traditional Chinese Medicine |
| Condition | Vascular Disease，Peripheral |
| Study Type | OBSERVATIONAL |
| Enrollment | 155 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 155 participants in total. It began in 2024-12-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: This study is a single-center prospective observational research that recorded patients' pain scores at four time points during surgery (puncture and catheter insertion, swelling fluid injection, microwave generator operation, and end of surgery). It analyzed the correlation between pain during microwave ablation treatment for great saphenous vein varicosities and factors such as age, gender, body mass index, volume of swelling fluid used, and others, in order to summarize and improve surgical details to reduce patients' intraoperative pain.
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06693245 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Vascular Disease，Peripheral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06693245 currently recruiting?
Yes, NCT06693245 is actively recruiting participants. Contact the research team at Chunshuihe@msn.com for enrollment information.
Where is the NCT06693245 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06693245 clinical trial?
NCT06693245 is sponsored by Chengdu University of Traditional Chinese Medicine. The trial plans to enroll 155 participants.