Microwaves Ablation of Varicose Veins

NCT ID: NCT05508581

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-12-15

Brief Summary

Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives.

Detailed Description

Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives. Endo venous thermal ablation, such as radiofrequency ablation and endo venous laser ablation (EVLA), has become the recommended first-line treatment for VVs worldwide. These endo venous procedures provide a quicker recovery time and improved QoL and produce fewer complications than traditional surgery .Endo venous microwaves ablation is a minimally invasive procedure in treatment of V.V, investigators confirmed that endo venous microwave ablation (EMA) was an effective new technique for the treatment of VVs. On previous trials confirmed that the endo venous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endo venous laser ablation procedure. The aim of the study was to determine whether endo venous microwave ablation of varicose vein was associated with better effectiveness and less complications and evaluate the outcome of patients who underwent endo venous microwave ablation (EMA).

Conditions

Varicose Veins

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Varicose veins

Ablation of varicose veins by microwaves

Group Type: OTHER

microwaves ablation of varicose veins

Intervention Type: PROCEDURE

Microwave ablation is an endovenous treatment. This is a similar treatment approach as laser ablation and radiofrequency ablation. "Endovenous" means that the treatment device is inside the vein during treatment.

Interventions

microwaves ablation of varicose veins

Microwave ablation is an endovenous treatment. This is a similar treatment approach as laser ablation and radiofrequency ablation. "Endovenous" means that the treatment device is inside the vein during treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 60 years, either sex, elective admission

2. primary symptomatic VVS (CEAP,C3-C6)

3. Recurrent Varicose Veins after surgery

4. Greater saphenous vein diameter up to 3 cm

5. Greater saphenous vein with variable depth even with depth less than 6mm

6. Greater saphenous vein with tortuosity

7. Diabetic patient with risk of wound infection after surgery

8. Patient with hostile groin

9. Availability of patients for all follow-up visits

Exclusion Criteria

1. secondary Varicose Veins

2. Acute thrombosis near the Saphenous-femoral junction

3. Recanalized Greater saphenous vein

4. pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

joseph samy youssef saleeb

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Gamal glal, Lecturer

Role: STUDY_CHAIR

Lecturer at Vascular and endovascular surgery department Assuit University

Locations

Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Microwaves ablation

Identifier Type: -

Identifier Source: org_study_id