Back to resultsTreatment of Great Saphenous Vein Varicosities
Primary Purpose
Varicose Veins
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endovenous chemical ablation with Trendelenburg's operation (eCAT)
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins
Eligibility Criteria
Inclusion Criteria: Patients presented by primary VV of the LL complaining of Leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at LL the incompetence of the saphenofemoral junction (SFJ) and or saphenopopliteal junction (SPJ). Exclusion Criteria: Lower limb involvement by any of the following conditions; secondary VV, recurrent VV, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia
Sites / Locations
- Walied Khereba
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lower limb varicose vein
Arm Description
Outcomes
Primary Outcome Measures
GSV Patency
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
GSV Patency
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
GSV Patency
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05655416
Brief Title
Treatment of Great Saphenous Vein Varicosities
Official Title
Endovenous Chemical Ablation and Trendlenburg Operation for the Treatment of Great Saphenous Vein Varicosities
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Venous insufficiency at lower extremities may result in clinical problems from cosmetic issues to ulcerations. When the frequency of venous insufficiency and its related problems are considered besides their diversity, it is encountered as a public health issue. This pathology is reported to affect 40% of women and 20% of men.1 Patients with varicose veins may complain of unsightly appearance, aching, heaviness, pruritus, and early fatigue of the affected leg. These symptoms worsen with prolonged standing and sitting and are relieved by elevation of the leg above the level of the heart. Also, mild edema is often present. More severe signs include thrombophlebitis, hyperpigmentation, lipodermatosclerosis, ulceration, and bleeding
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
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower limb varicose vein
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Endovenous chemical ablation with Trendelenburg's operation (eCAT)
Intervention Description
Endovenous chemical ablation with trendelenburg's operation (e CAT) is a method for the treatment of varicose veins
Primary Outcome Measure Information:
Title
GSV Patency
Description
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
Time Frame
at one week post operative
Title
GSV Patency
Description
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
Time Frame
at one month post operative
Title
GSV Patency
Description
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
Time Frame
at one year post operative
10. Eligibility
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presented by primary VV of the LL complaining of Leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at LL
the incompetence of the saphenofemoral junction (SFJ) and or saphenopopliteal junction (SPJ).
Exclusion Criteria:
Lower limb involvement by any of the following conditions; secondary VV, recurrent VV, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia
Facility Information:
Facility Name
Walied Khereba
City
Zagazig
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Treatment of Great Saphenous Vein Varicosities
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