Status:
UNKNOWN
MicrOwave and laSer ablaTion Study (MOST Study)
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Conditions:
Varicose Veins of Lower Limb
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 18 years or older, not older than 80 years, male or female
- Patients clinically diagnosed as primary great saphenous vein insufficiency with reflux lasting \> 0.5 seconds on duplex ultrasound
- Patients with CEAP grade C2-C6
- Patients who voluntarily participate in this trial, understand all the risks and benefits described in the informed consent document, and sign the written informed consent form
Exclusion
- Patients with diameter of target lesion vein \< 2 mm or \> 15 mm
- Patients with previous surgical treatment on the target lesion or patients with acute thrombosis
- Patients with deep vein thrombosis and superficial vein thrombosis
- Patients with acute systemic infectious diseases
- Patients with severe liver and kidney dysfunction (ALT \> 3 times the upper limit of normal value; creatinine \> 225 umol /L)
- Patients with known uncorrectable bleeding or severe coagulopathy
- Patients with anesthesia contraindications
- Patients with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and diabetes mellitus (fasting glucose ≥ 10.0 mmol / L)
- Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, KT syndrome (Klippel-Trenaunay syndrome), arteriovenous fistula, etc.
- Patients with other diseases that may cause difficulty in conducting the trial or evaluation, such as mental illness, AIDS, malignant tumors, liver disease, cardiac insufficiency, etc. or patients whose life expectancy is less than 1 year
- Pregnant, lactating women, or those planning on becoming pregnant during the trial
- Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months
- Patients considered unsuitable for inclusion by investigators for other reasons
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04726124
Start Date
January 26 2021
End Date
September 28 2022
Last Update
March 23 2022
Active Locations (1)
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1
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing Municipality, China, 102218