Back to resultsMicrOwave and laSer ablaTion Study (MOST Study) (MOST)
Primary Purpose
Varicose Veins of Lower Limb
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microwave Ablation Therapeutic Apparatus
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring endovenous microwave therapy（EMT）, endovenous laser treatment（EVLT）, great saphenous vein
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Beijing Tsinghua Chang Gung Hosipital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
treatment group
control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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%
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.
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.
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.
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.
Full Information
NCT ID
NCT04726124
First Posted
January 22, 2021
Last Updated
March 22, 2022
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04726124
Brief Title
MicrOwave and laSer ablaTion Study (MOST Study)
Acronym
MOST
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
September 28, 2022 (Anticipated)
Study Completion Date
September 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb
Keywords
endovenous microwave therapy（EMT）, endovenous laser treatment（EVLT）, great saphenous vein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Microwave Ablation Therapeutic Apparatus
Other Intervention Name(s)
Semiconductor Laser Treatment Apparatus
Intervention Description
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.
Primary Outcome Measure Information:
Title
the complete closure rate of great saphenous vein at 6 months after surgery
Description
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.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
the complete closure rate of great saphenous vein at 12 months after surgery
Description
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.
Time Frame
12 months after surgery
Title
surgical success rate
Description
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%
Time Frame
immediately after surgery
Title
device performance evaluation
Description
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.
Time Frame
during or after surgery
Title
changes of venous clinical severity score (VCSS) before and after treatment
Description
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.
Time Frame
screening period, 30days, 3 months, 6months, 12 months after surgery
Title
changes of Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment
Description
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.
Time Frame
screening period, 30 days, 3 months, 6 months, 12 months after surgery
Title
time of surgery
Description
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.
Time Frame
immediately after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
weiwei Wu, M.D.
Organizational Affiliation
Beijing Tsinghua Chang Gung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tsinghua Chang Gung Hosipital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35613801
Citation
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.
Results Reference
derived
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MicrOwave and laSer ablaTion Study (MOST Study)
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