An observational study in Vascular Disease，Peripheral, Venous Insufficiency of Leg and Varicose Veins of Lower Limb, sponsored by Chengdu University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Chengdu University of Traditional Chinese Medicine · Observational
Among 22 studies in Peripheral Vascular Diseases with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Peripheral Vascular Diseases · China.
Among the 22 studies in Peripheral Vascular Diseases with a site in China, this one is one of 4 that started in 2024, is one of 4 observational ones, and was the 20th registered.
443 studies on the registry are indexed under Peripheral Vascular Diseases; 44 are open to participants now.
This study's planned enrollment of 155 is below the median of 217 across 86 observational studies indexed under Peripheral Vascular Diseases.
Browse Peripheral Vascular Diseases studies →7 of the 22 studies in Peripheral Vascular Diseases with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 32 Peripheral Vascular Diseases studies recruiting now, 19 (59%) set no upper age limit and 4 (13%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 4 started in 2024.
Median enrollment 200 across the 18 interventional studies, 198 across the 4 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
8 of 22 have an industry lead sponsor. The 10 most frequent:
Chengdu University of Traditional Chinese Medicine is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
Chengdu University of Traditional Chinese Medicine has 7 studies filed under Peripheral Vascular Diseases — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Peripheral Vascular Diseases with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Despite the significant progress made by global experts in vascular surgery in studying endovenous microwave ablation (EMA) for the treatment of varicose veins (VVs), there are still many unknown areas to be explored. Current research primarily focuses on the surgical outcomes and associated complications of EMA, while studies on intraoperative pain are relatively scarce. Firstly, the American College of Radiology has not provided a clear definition of intraoperative pain when treating lower extremity varicose veins, thus it has not received sufficient attention in clinical practice. Many physicians consider the success of the surgery as the endpoint of treatment, overlooking the impact of intraoperative pain on the patient's surgical experience. Ni Zhao et al. found in a prospective randomized controlled trial that EMA is associated with more pain within 48 hours post-operation. When our department introduced the use of EMA for VVs, we discovered that its working form and power differ from other thermal ablations, and there are also differences in terms of intraoperative pain, the volume of tumescent fluid used, and the requirements for vein depth. With the continuous advancement in lower limb varicose vein surgeries, anesthesia methods have evolved from general anesthesia to combined spinal-epidural anesthesia, and now to local anesthesia. Tumescent anesthetic solution is the main anesthetic agent for EMA surgery, and the infiltration of tumescent anesthetic fluid around the great saphenous vein is crucial for the success of EMA; however, paradoxically, this is also the area where patients experience the most severe pain. The commonly used tumescent solution is a crystalline solution containing local anesthetics and adrenaline, which is acidic in nature and is the main reason for the 'sting' sensation during skin infiltration. A Cochrane review indicated that adjusting the pH of lidocaine solution by adding sodium bicarbonate significantly reduced pain during the skin infiltration process, as measured by the 10-centimeter Visual Analog Scale (VAS). Moreover, the temperature of the tumescent anesthetic solution also affects pain during the skin infiltration process, as noted by Bell et al. Alonso et al. found in a prospective randomized controlled trial that heating local anesthetic solutions to 37°C and 42°C can reduce pain, and heating adrenaline-containing local anesthetic solutions to near body temperature is also an effective method to alleviate local anesthetic pain. We hope to achieve better preoperative prevention and intraoperative management through an analysis of pain-related factors, thereby improving the patient's surgical experience.
Patients diagnosed with primary VVs from December 2024 to December 2025 who were admitted to the hospital and underwent endovenous microwave ablation treatment for the main trunk of the saphenous vein
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Among 155 patients, our team measured the diameter of the great saphenous vein preoperatively according to the CEAP classification and ultrasound measurements. We performed endovenous microwave ablation of the great saphenous vein along with foam sclerotherapy and point stripping treatment. We documented the operating room temperature, puncture site, VAS scores during puncture and catheter placement, the amount of injected tumescent fluid, radiofrequency generator used, and data at the conclusion of the surgery. A descriptive analysis of intraoperative pain scores was conducted to evaluate the level of pain experienced during the surgery. A nonparametric test was utilized to analyze the relationship between preoperative and intraoperative factors and the level of pain experienced during the surgery.
Procedure: VAS scores of the puncture
All patients were evaluated by our team with CEAP grading and ultrasound measurements to record the diameter of the saphenous vein before surgery。We performed endovenous microwave ablation of the great saphenous vein along with foam sclerotherapy and point stripping treatment. We documented the operating room temperature, puncture site, VAS scores during puncture and catheter placement, the amount of injected tumescent fluid, radiofrequency generator used, and data at the conclusion of the surgery. A descriptive analysis of intraoperative pain scores was conducted to evaluate the level of pain experienced during the surgery. A nonparametric test was utilized to analyze the relationship between preoperative and intraoperative factors and the level of pain experienced during the surgery.
Visual Analogue Scale (VAS) Pain Score
We mainly record the VAS pain scores during local anesthetic injection, needle puncture, catheter placement, swollen anesthetic injection, microwave generator operation, and at the end of the surgery.
Time frame: during operation
Basic data related to surgery
We also documented the patient's heart rate, blood pressure, oxygen saturation, along with the temperature of the operating room, location of puncture, number of incisions, and volume of injected swelling fluid, among others. These data are recorded to explore their correlation with the intraoperative VAS pain score.
Time frame: intraoperative
Plan to share: No
Start is estimated for Dec 2024; primary completion for Dec 2025, 12 months later.
Of 25 observational studies under Peripheral Vascular Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 95. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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Chengdu University of Traditional Chinese Medicine