Microwaves Ablation of Varicose Veins

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: microwaves ablation of varicose veins

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Varicose veins; Ablation of varicose veins by microwaves	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Number of Participants with Lack of flow or closed great saphenous vein	Complete ablation of varicose veins done or if any residual remind	6 months
2.Operation time	The time of the whole procedure	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation	Reopening of the Varicose veins	12 month
2. Number of Participants with adverse effect of the procedure	Thrombophlebitis,Infection or blood loss	12 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohamed Gamal glal, Lecturer, Lecturer at Vascular and endovascular surgery department Assuit University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: Microwaves ablation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No