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Completed

NCT Number: NCT05508581

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Asyut, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 1.Number of Participants with Lack of flow or closed great saphenous vein

    Time frame: 6 months

    Complete ablation of varicose veins done or if any residual remind

  2. 2.Operation time

    Time frame: Intraoperative

    The time of the whole procedure

Secondary outcomes

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

    Time frame: 12 month

    Reopening of the Varicose veins

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

    Time frame: 12 months

    Thrombophlebitis,Infection or blood loss

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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