Microwaves Ablation of Varicose Veins

Varicose Veins Clinical Trial

Official title:

Microwaves Ablation of Varicose Veins

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05508581
• Other study ID #: Microwaves ablation
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: joseph samy youssf saleeb, resident
• Phone: 01015654718
• Email: josephsamy95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

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.

Locations

Country	Name	City	State
Egypt	Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	2.Operation time	The time of the whole procedure	Intraoperative
Secondary	1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation	Reopening of the Varicose veins	12 month
Secondary	2. Number of Participants with adverse effect of the procedure	Thrombophlebitis,Infection or blood loss	12 months