MicrOwave and laSer ablaTion Study (MOST Study) (MOST)

• ClinicalTrials.gov Identifier: NCT04726124
• Recruitment Status: Active, not recruiting
• First Posted: January 27, 2021
• Last Update Posted: January 18, 2022
• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Information provided by (Responsible Party): Beijing Tsinghua Chang Gung Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Varicose Veins of Lower Limb	Device: Microwave Ablation Therapeutic Apparatus	Not Applicable

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 lower extremities

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: January 26, 2021
• Estimated Primary Completion Date: February 28, 2022
• Estimated Study Completion Date: February 28, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: treatment group; 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, and 6 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate.	Device: Microwave Ablation Therapeutic Apparatus; 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 and 6 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.; Other Name: Semiconductor Laser Treatment Apparatus
Experimental: control group; 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, and 6 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate.	Device: Microwave Ablation Therapeutic Apparatus; 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 and 6 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.; Other Name: Semiconductor Laser Treatment Apparatus

Outcome Measures

Primary Outcome Measures :

1. the complete closure rate of great saphenous vein at 6 months after surgery [ Time Frame: 6 months after operation ]
   counting data

Secondary Outcome Measures :

1. surgical success rate [ Time Frame: immediately after operation ]
   counting data
2. device performance evaluation [ Time Frame: immediately after operation ]
   counting data
3. changes of venous clinical severity score (VCSS) before and after treatment [ Time Frame: 6 months after operation ]
   counting data
4. changes of Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment [ Time Frame: 6 months after operation ]
   counting data
5. time of surgery [ Time Frame: immediately after operation ]
   counting data

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age 18 years or older, not older than 80 years, male or female
2. Patients clinically diagnosed as primary varicosis of great saphenous vein of the lower extremities
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
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

Contacts and Locations

Locations

China, Beijing

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing, China, 102218

Sponsors and Collaborators

Beijing Tsinghua Chang Gung Hospital

Investigators

• Principal Investigator: weiwei Wu, M.D.; Beijing Tsinghua Chang Gung Hospital

More Information

• Responsible Party: Beijing Tsinghua Chang Gung Hospital
• ClinicalTrials.gov Identifier: NCT04726124
• Other Study ID Numbers: SD-LC-001
• First Posted: January 27, 2021
• Last Update Posted: January 18, 2022
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beijing Tsinghua Chang Gung Hospital:

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

Additional relevant MeSH terms:

Varicose Veins; Vascular Diseases; Cardiovascular Diseases