Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT07907315
Active, not recruiting Observational

Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave

NCT07907315 · tracked via the Priya Life Science China tracker
Sponsor
Chunshui He
Phase
Observational
Started
2026-09-01
Last updated
2026-10-30

Condition(s) studied

Lower Extremity Varicose VeinsRadiofrequency AblationMicrowave AblationPain Measurement

Investigational drug(s) / intervention(s)

Radiofrequency ablationMicrowave Ablation

Radiofrequency ablation: Endovenous thermal ablation of the incompetent great saphenous vein (GSV) using radiofrequency energy. The procedure is performed under tumescent local anesthesia (TLA). The device delivers segmental radiofrequency energy (460 kHz) through a catheter placed within the GSV, heating the vein wall to approximately 120°C, causing collagen contraction and vein occlusion.

Microwave Ablation: Endovenous thermal ablation of the incompetent great saphenous vein (GSV) using microwave energy. The procedure is performed under tumescent local anesthesia (TLA). The device delivers microwave energy (2450 MHz) through an antenna placed within the GSV, generating dielectric heating that causes thermal coagulation and vein closure.

Study summary

This study compares two common heat-based procedures for treating varicose veins in the legs: radiofrequency ablation (RFA) and microwave ablation (MWA). Both treatments use heat to close off diseased veins, but they work differently-RFA heats through direct contact, while MWA uses microwave energy that spreads heat more widely.

The main question is: Which procedure causes less pain during the surgery?

Participants will be randomly assigned to receive either RFA or MWA. Since the surgery is done under local anesthesia (not general anesthesia), patients remain awake throughout. We will measure their pain at four key moments:

When the needle is first inserted

Right after injecting the numbing fluid (tumescent anesthesia)

During the heat treatment itself

At the end of the entire procedure

We will also track how much numbing fluid is used, how long the procedure takes, and any side effects. Patients will be followed for 30 days after surgery to monitor recovery and satisfaction.

The goal is to find out whether one method is more comfortable for patients, and to identify which factors (such as age, vein size, or anxiety level) affect pain during each procedure. This will help doctors choose the best approach for each patient and improve the overall treatment experience.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age 18 to 75 years, male or female. 2. Confirmed diagnosis of great saphenous vein (GSV) trunk reflux with a reflux time \>0.5 seconds on lower extremity duplex ultrasound. 3. CEAP clinical classification of C2 to C6 (inclusive). 4. GSV trunk diameter (thigh segment) measuring 4 to 12 mm on pre-operative ultrasound. 5. Planned to undergo endovenous thermal ablation treatment for varicose veins. 6. Willing and able to provide written informed consent to participate in the study. Exclusion Criteria: 1. History of deep vein thrombosis (DVT) in the ipsilateral lower extremity. 2. ior surgical stripping or endovenous ablation treatment on the ipsilateral GSV. 3. Acute superficial venous thrombophlebitis in the ipsilateral lower extremity at the time of screening. 4. Concurrent lower extremity arterial disease with an ankle-brachial index (ABI) \<0.7. 5. Pregnancy or currently breastfeeding. 6. Known allergy or hypersensitivity to lidocaine, ropivacaine, or any amide-type local anesthetic agent. 7. Severe hepatic impairment (ALT or AST \>3 times the upper limit of normal). 8. Severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73m²). 9. Severe cardiac dysfunction (New York Heart Association Class III or IV) or uncontrolled cardiac arrhythmia. 10. Coagulation abnormality (international normalized ratio \>1.5 or platelet count \<80 × 10⁹/L). 11. Diagnosis of severe psychiatric disorder or cognitive impairment that would interfere with the ability to provide reliable Visual Analog Scale (VAS) pain scores. 12. Planned bilateral simultaneous ablation procedure (both legs treated in the same session). 13. Chronic pain syndrome or long-term use of analgesic medications (regular use for \>3 months). 14. Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation.

Primary outcome measure(s)

  • Pain Score at Tumescent Anesthesia Injection Completion (VAS-T2) — Measured immediately after TLA injection is completed and ultrasound confirms satisfactory perivenous fluid infiltration (before ablation begins) - Intraoperative (Day 0)
    Pain intensity immediately after completion of tumescent local anesthesia (TLA) injection, assessed using the Visual Analog Scale (VAS). VAS is a clinical assessment tool that quantifies pain intensity using a linear scale approximately 10 centimeters long. The two ends of the scale are marked as "0" (no pain) and "10" (worst imaginable pain).The patient reports the most significant pain experienced during the entire TLA injection phase (from the first puncture to completion of injection).
  • Pain Score During Catheter Ablation (VAS-T3) — Measured immediately after completion of GSV trunk ablation and withdrawal of the ablation catheter
    Pain intensity during the endovenous ablation phase, assessed using the Visual Analog Scale (VAS). The patient reports the most significant pain experienced during the entire ablation phase (from activation of the ablation device to completion of great saphenous vein trunk ablation).Visual Analog Scale (VAS): Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity). A score of 0 represents "no pain" and a score of 10 represents "worst imaginable pain."

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu Sichuan

More Chunshui He trials in China

Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis Starting soon

Other trials for the same condition

Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy Recruiting
Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over Recruiting
Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma Recruiting
Efficacy and Prognosis of Microwave Ablation Treatment for Papillary Thyroid Microcarcinoma Assessed by Contrast-Enhanced Ultrasound Combined With Genetic and Molecular Diagnostics: A Prospective Observational Study Recruiting
RFA Plus Carrizumab vs Carrizumab Alone for HCC Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07907315 on ClinicalTrials.gov ↗ ← All trials in China