Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Pa… (NCT07233616) | Clinical Trial Compass
RecruitingNot Applicable
Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over
China50 participantsStarted 2025-10-01
Plain-language summary
The prevalence of severe chronic venous insufficiency (CVI) is significant in the growing octogenarian population. While radiofrequency ablation (RFA) is a standard minimally invasive treatment, robust data on its outcomes and safety profiles specifically in patients aged 80 years and older remain scarce. This study aims to evaluate the risks and benefits of RFA in this specific, high-risk demographic.This prospective, single-arm, single-center cohort study will enroll 50 patients (initial target sample size) aged ≥80 years with CVI classified as CEAP C3 to C6 and with confirmed great or small saphenous vein reflux. All participants will undergo endovenous RFA under tumescent local anesthesia. The primary outcomes are: 1) the great/small saphenous vein occlusion rate at 6 months, assessed by duplex ultrasonography, and 2) the change in disease-specific quality of life from baseline to 6 months, measured by the Aberdeen Varicose Vein Questionnaire (AVVQ). Secondary outcomes include occlusion rates at 1 and 3 months; complication rates (e.g., deep vein thrombosis, skin burns, paresthesia) within 30 days; and changes in the Venous Clinical Severity Score (VCSS) and the 12-Item Short Form Health Survey (SF-12) at predefined intervals over 6 months.This study is designed to demonstrate a high technical success rate (occlusion rate \>95% at 6 months) and a statistically significant improvement in AVVQ and VCSS scores at 6 months post-procedure. The collected data will provide a detailed profile of complication rates, characterizing the safety of RFA in this very elderly cohort.This study will provide crucial, prospective evidence regarding the efficacy and safety of RFA for treating CVI in octogenarians. The findings are expected to guide clinical decision-making and inform treatment guidelines for this vulnerable and expanding patient population.
Who can participate
Age range
80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: Aged 80 years or older.
. Clinical Diagnosis: Symptomatic chronic venous insufficiency of the lower extremity, with the highest clinical class (CEAP classification) being one of the following:
. Confirmed Reflux: Color duplex ultrasound examination confirming reflux (reflux time \> 0.5 seconds) in the great saphenous vein (GSV) and/or small saphenous vein (SSV) of the target limb.
. Informed Consent: The patient or their legally authorized representative is able to understand and voluntarily provides written informed consent.
Exclusion criteria
. Mobility: Non-ambulatory or bedridden.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Great/Small Saphenous Vein Occlusion Rate at 6 Months
Timeframe: 6 Months
2
Aberdeen Varicose Vein Questionnaire (AVVQ)
Timeframe: 6 Months
Trial details
NCT IDNCT07233616
SponsorChengdu University of Traditional Chinese Medicine
. Allergy: Known severe allergy to local anesthetics (e.g., lidocaine) or relevant device materials.
. Cognition \& Compliance: Severe cognitive impairment or psychiatric illness that, in the investigator's judgment, precludes adequate understanding and cooperation for the study procedures and follow-up.
. Life Expectancy: Life expectancy of less than 1 year due to other comorbid conditions (e.g., terminal malignancy).
. General Unsuitability: Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.