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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Microwave Ablation Therapeutic Apparatus. Patients with primary lower extremity varicose veins were treated with endovenous microwave therapy using Microwave Ablation Therapy Apparatus. Ultrasound examination and questionnaire survey（AVVQ and VCSS) were performed at 1 week, 3 months, 6 months,12 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate. |
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| control group | Experimental | Semiconductor Laser Treatment Apparatus. Patients with primary lower extremity varicose veins were treated with endovenous laser treatment using Semiconductor Laser Treatment Apparatus. Ultrasound examination and questionnaire survey（AVVQ and VCSS) were performed at 1 week, 3 months, 6 months, 12 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave Ablation Therapeutic Apparatus | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| weiwei Wu, M.D. | Beijing Tsinghua Chang Gung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Chang Gung Hosipital | Beijing | Beijing Municipality | 102218 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35613801 | Derived | Li Y, Wu W, Li Y, Li J, Sun M. Efficacy and safety of endovenous microwave ablation versus laser ablation for great saphenous vein varicosis: study protocol for a multicentre, randomised controlled non-inferiority trial. BMJ Open. 2022 May 25;12(5):e059213. doi: 10.1136/bmjopen-2021-059213. |
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| 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% | 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. | 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. | 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. | 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. | immediately after surgery |