Microwaves Ablation of Varicose Veins

NCT05508581 | Completed

• 1 other identifier: Microwaves ablation
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation

  12 month

• 2. Number of Participants with adverse effect of the procedure

  12 months

Study Arms (1)

Varicose veins

OTHER

Ablation of varicose veins by microwaves

Procedure: microwaves ablation of varicose veins

Interventions

microwaves ablation of varicose veins 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.

Varicose veins

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years, either sex, elective admission
• primary symptomatic VVS (CEAP,C3-C6)
• Recurrent Varicose Veins after surgery
• Greater saphenous vein diameter up to 3 cm
• Greater saphenous vein with variable depth even with depth less than 6mm
• Greater saphenous vein with tortuosity
• Diabetic patient with risk of wound infection after surgery
• Patient with hostile groin
• Availability of patients for all follow-up visits

You may not qualify if:

• secondary Varicose Veins
• Acute thrombosis near the Saphenous-femoral junction
• Recanalized Greater saphenous vein
• pregnancy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

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

Asyut, Egypt

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mohamed Gamal glal, Lecturer

  Lecturer at Vascular and endovascular surgery department Assuit University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: August 19, 2022
• Study Start: November 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 15, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)