MicrOwave and laSer ablaTion Study (MOST Study)

NCT04726124 | Unknown DMC

• 1 other identifier: SD-LC-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Varicose Veins of Lower Limb

Keywords

endovenous microwave therapy（EMT）; endovenous laser treatment（EVLT）; great saphenous vein

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• the complete closure rate of great saphenous vein at 12 months after surgery

  12 months after surgery

• surgical success rate

  immediately after surgery

• device performance evaluation

  during or after surgery

• changes of venous clinical severity score (VCSS) before and after treatment

  screening period, 30days, 3 months, 6months, 12 months after surgery

• changes of Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment

  screening period, 30 days, 3 months, 6 months, 12 months after surgery

Study Arms (2)

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.

Device: Microwave Ablation Therapeutic Apparatus

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.

Device: Microwave Ablation Therapeutic Apparatus

Interventions

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.

Also known as: Semiconductor Laser Treatment Apparatus

control group; treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, 102218, China

Location

Related Publications (1)

• 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.

  PMID: 35613801 DERIVED

Study Officials

• weiwei Wu, M.D.

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: January 26, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: March 23, 2022

Record last verified: 2021-10

Locations

CN (1)