Observation of Pain During Radiofrequency Ablation of Saphenous Vein，and Analysis of Related Factors (NCT07683871) | Clinical Trial Compass
CompletedNot Applicable
Observation of Pain During Radiofrequency Ablation of Saphenous Vein，and Analysis of Related Factors
China155 participantsStarted 2024-07-01
Plain-language summary
Objective: This study is a single-center prospective observational study, which recorded the pain scores of patients at four time nodes during surgery (puncture and catheterization, injection of swelling fluid, radiofrequency generator work, and end of surgery), and analyzed the correlation between intraoperative pain and age, gender, BMI and other factors, so as to summarize and improve the details of surgery and reduce patients' intraoperative pain.
Who can participate
Age range
18 Years – 90 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≥ 18 years old, ≤ 90 years old;
. the patient's life expectancy is greater than 12 months;
. 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;
. Doppler ultrasound confirmed that the diameter of GSV was greater than 3mm and less than 12mm when standing;
. Doppler ultrasound confirms that GSV is located in the saphenofascia or the distance between GSV and the skin surface is \>1cm;
. radiofrequency ablation treatment only for unilateral GSV walking area;
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
Puncture catheterization
Timeframe: At the time of surgery
2
Inject swollen fluid
Timeframe: At the time of surgery
Trial details
NCT IDNCT07683871
SponsorChengdu University of Traditional Chinese Medicine