MicrOwave and laSer ablaTion Study (MOST Study)

Beijing Tsinghua Chang Gung Hospital

Status: Unknown

Conditions: Varicose Veins of Lower Limb

Treatments: Device: Microwave Ablation Therapeutic Apparatus

Study type: Interventional

Funder types: Other

Identifiers

NCT04726124

SD-LC-001

Details and patient eligibility

About

To validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities

Full 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 lower extremities

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older, not older than 80 years, male or female
2. Patients clinically diagnosed as primary great saphenous vein insufficiency with reflux lasting > 0.5 seconds on duplex ultrasound
3. Patients with CEAP grade C2-C6
4. 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 criteria

1. Patients with diameter of target lesion vein < 2 mm or > 15 mm
2. Patients with previous surgical treatment on the target lesion or patients with acute thrombosis
3. Patients with deep vein thrombosis and superficial vein thrombosis
4. Patients with acute systemic infectious diseases
5. Patients with severe liver and kidney dysfunction (ALT > 3 times the upper limit of normal value; creatinine > 225 umol /L)
6. Patients with known uncorrectable bleeding or severe coagulopathy
7. Patients with anesthesia contraindications
8. 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)
9. Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, KT syndrome (Klippel-Trenaunay syndrome), arteriovenous fistula, etc.
10. 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
11. Pregnant, lactating women, or those planning on becoming pregnant during the trial
12. Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months
13. Patients considered unsuitable for inclusion by investigators for other reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

treatment group

Experimental group

Description:

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.

Treatment:

Device: Microwave Ablation Therapeutic Apparatus

control group

Experimental group

Description:

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.

Treatment:

Device: Microwave Ablation Therapeutic Apparatus