MicrOwave and laSer ablaTion Study (MOST Study)

NCT ID: NCT04726124

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2022-09-28

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

Conditions

Varicose Veins of Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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, 6 months,12 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate.

Group Type: EXPERIMENTAL

Microwave Ablation Therapeutic Apparatus

Intervention Type: 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.

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, 6 months, 12 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate.

Group Type: EXPERIMENTAL

Microwave Ablation Therapeutic Apparatus

Intervention Type: 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.

Interventions

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, 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.

Intervention Type: DEVICE

Other Intervention Names

Semiconductor Laser Treatment Apparatus

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

weiwei Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Chang Gung Hospital

Locations

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35613801 (View on PubMed)

Other Identifiers

SD-LC-001

Identifier Type: -

Identifier Source: org_study_id