Microwaves Ablation of Varicose Veins
Primary Purpose
Varicose Veins
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
microwaves ablation of varicose veins
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins
Eligibility Criteria
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
Sites / Locations
- Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Varicose veins
Arm Description
Ablation of varicose veins by microwaves
Outcomes
Primary Outcome Measures
1.Number of Participants with Lack of flow or closed great saphenous vein
Complete ablation of varicose veins done or if any residual remind
2.Operation time
The time of the whole procedure
Secondary Outcome Measures
1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation
Reopening of the Varicose veins
2. Number of Participants with adverse effect of the procedure
Thrombophlebitis,Infection or blood loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05508581
Brief Title
Microwaves Ablation of Varicose Veins
Official Title
Microwaves Ablation of Varicose Veins
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Varicose veins
Arm Type
Other
Arm Description
Ablation of varicose veins by microwaves
Intervention Type
Procedure
Intervention Name(s)
microwaves ablation of varicose veins
Intervention Description
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 Outcome Measure Information:
Title
1.Number of Participants with Lack of flow or closed great saphenous vein
Description
Complete ablation of varicose veins done or if any residual remind
Time Frame
6 months
Title
2.Operation time
Description
The time of the whole procedure
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation
Description
Reopening of the Varicose veins
Time Frame
12 month
Title
2. Number of Participants with adverse effect of the procedure
Description
Thrombophlebitis,Infection or blood loss
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
joseph samy youssf saleeb, resident
Phone
01015654718
Email
josephsamy95@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed gamal glal, lecturer
Phone
01005443747
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Gamal glal, Lecturer
Organizational Affiliation
Lecturer at Vascular and endovascular surgery department Assuit University
Official's Role
Study Chair
Facility Information:
Facility Name
Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years
City
Asyut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Microwaves Ablation of Varicose Veins
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