To validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities
A prospective, multicenter, randomized, controlled clinical trial to validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
The selected and qualified subjects with primary lower extremity varicose veins were randomly treated with microwave ablation equipment or laser treatment equipment. Subjects in the two groups were returned to the hospital for follow-up at 7 days, 3 months, 6 months, 12 months after surgery, respectively, for ultrasound examination and questionnaire evaluation, medication status and adverse events were recorded, and target lesion closure rate and subject satisfaction were evaluated.
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing Municipality, China
the complete closure rate of great saphenous vein at 6 months after surgery
Complete closure: Doppler ultrasonography showed that the target vein segment of the entire treatment is closed, with no discontinuous unclosed segment more than 5 cm. Calculation method: Complete closure rate = number of subjects with complete closure of target vein in the group/total number of subjects in the same group × 100%. The B-ultrasound check is performed on subjects 6 months after the surgery for whether the target vein is completely closed, the result is recorded. After the trial is completed, the number of subjects whose target vein is completely closed is counted, and the complete closure rate of great saphenous vein is calculated.
Time frame: 6 months after surgery
the complete closure rate of great saphenous vein at 12 months after surgery
Complete closure: Doppler ultrasonography showed that the target vein segment of the entire treatment is closed, with no discontinuous unclosed segment more than 5 cm. Calculation method: Complete closure rate = number of subjects with complete closure of target vein in the group/total number of subjects in the same group × 100%. The B-ultrasound check is performed on subjects 12 months after the surgery for whether the target vein is completely closed, the result is recorded. After the trial is completed, the number of subjects whose target vein is completely closed is counted, and the complete closure rate of great saphenous vein is calculated.
Time frame: 12 months after surgery
surgical success rate
Successful surgery: Doppler ultrasound examination shows that the target lesion segment is closed immediately after operation. Calculation method: Surgical success rate = number of subjects successfully operated in this group/total number of subjects in this group × 100%
Time frame: immediately after surgery
device performance evaluation
During or after the surgery, the manipulation performance of the device is evaluated by the investigator,which is include flexibility, passability, ease of use, accuracy, stability etc.. Only the device in the test group is evaluated.
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Time frame: during or after surgery
changes of venous clinical severity score (VCSS) before and after treatment
VCSS is performed in the screening period, 30 days after surgery, 3 months and 6 months after surgery. The VCSS includes 10 items, namely, pain, varicose veins, edema, skin pigmentation, inflammation, skin induration, number of active ulcers, ulcer size, duration of ulcers and application of compression therapy. Each item is scored from 0 to 3 according to the severity of the disease, with a total score of 30. The higher the score, the more serious the condition.
Time frame: screening period, 30days, 3 months, 6months, 12 months after surgery
changes of Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment
Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment AVVQ score is performed in the screening period, 30 days after surgery, 3 months and 6 months after surgery. AVVQ includes the scope of varicose veins, the degree of pain, edema, itching, pigmentation, rash and ulcers, the use of painkillers and elastic stockings, the psychological worries, and the influence of varicose veins on daily clothing, work, life and sports. Each item is scored from 0 to 3 according to the severity of the disease. The lower the score, the better the quality of life.
Time frame: screening period, 30 days, 3 months, 6 months, 12 months after surgery
time of surgery
After the surgery, the operation time is recorded. The operation time is defined as the time from the entry of the investigational device into the vein to the withdrawal of the vein after the treatment.
Time frame: immediately after surgery