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Efficacy and Safety of Cold Tumescent Anesthesia in Endovenous Thermal Ablation for Lower Limb Varicose Veins: A Multicenter, Prospective, Randomized Controlled Trial

Efficacy and Safety of Cold Tumescent Anesthesia in Endovenous Thermal Ablation for Lower Limb Varicose Veins: A Multicenter, Prospective, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128782
Enrollment
Unknown
Registered
2026-07-26
Start date
2026-07-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower limb varicose veins

Interventions

Control group: Warm tumescent anesthesia solution (24? ± 1?)
:Radiofrequency venous closure system was adopted, with a radiofrequency generator used in combination with an endovenous radiofrequency catheter for treatment. Under B-mode ultrasound guidance, punct

Sponsors

Department of Intervention Radiology & Vascular Surgery,Tangdu Hospital, The Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Through color Doppler ultrasound examination, the diagnosis of primary lower extremity varicose veins was confirmed; 2. Age 18 to 75 years old, gender not limited; 3. CEAP classification: C2 to C6; 4. The main trunk of the varicose great saphenous vein has a diameter of 10mm = 1 year; 7. Can tolerate surgery; 8. No mental disorders; 9. Main organ functions are normal; 10. No history of anesthesia allergy; 11. Patients who agree to participate in this study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combine lower extremity DVT (deep vein thrombosis); 2. Acute thrombosis in the main trunk of the great saphenous vein; 3. Iliac vein compression syndrome; 4. The distance between the target lesion vessel's anterior wall and the skin is less than 0.5 cm under ultrasound; 5. The target lesion vessel has previously undergone surgical treatment; 6. Ultrasound shows rare distortion of the great saphenous vein; 7. Uncorrected coagulation dysfunction; 8. The values obtained from cardiac color Doppler ultrasound are not within the normal range, suggesting severe cardiac abnormalities; 9. There is a history of DVT recurrence or pulmonary embolism, accompanied by local or systemic infection; 10. There is a history of thrombotic superficial phlebitis that has led to partial obstruction of the great saphenous vein; 11. Bed rest; 12. Carprini score >= 5 points; 13. Pregnant or lactating; 14. Diabetic microcirculation disorder; 15. Participating in other clinical research of devices or drugs; 16. The investigator judges that the subject is not suitable to participate in this clinical research.

Design outcomes

Primary

MeasureTime frame
Target vein occlusion ;

Secondary

MeasureTime frame
Diameter of the target vein;Venous Clinical Severity Score;Visual Analogue Scale;Chronic Venous Insufficiency Quality of Life Questionnaire-20;Intraoperative adverse events (IAEs) ;

Countries

China

Contacts

Public ContactSonglin Guo

Department of Intervention Radiology & Vascular Surgery,Tangdu Hospital, The Fourth Military Medical University

pineforestguo@163.com+86 29 8471 7580

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026