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CompletedNCT05655416Updated Dec 19, 2022

Treatment of Great Saphenous Vein Varicosities

An interventional study of Endovenous chemical ablation with Trendelenburg's operation (eCAT) in Varicose Veins, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-19.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 8 months after the study started (first participant enrolled Apr 2014, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
20 Years to 60 Years
01

Study 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

02

Conditions studied

  • Varicose Veins

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03

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 55 is below the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Other
    Lower limb varicose vein

    Procedure: Endovenous chemical ablation with Trendelenburg's operation (eCAT)

Interventions

  • ProcedureEndovenous chemical ablation with Trendelenburg's operation (eCAT)

    Endovenous chemical ablation with trendelenburg's operation (e CAT) is a method for the treatment of varicose veins

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at one week post operative

  2. 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.

    Time frame: at one month post operative

  3. 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.

    Time frame: at one year post operative

07

Study locations

1 site
  • Walied Khereba
    Zagazig, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05655416
Lead sponsor
Al-Azhar University
Responsible party
Walied Khereba (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Dec 19, 2022
Start date
Apr 1, 2014
Primary completion
Apr 1, 2021
Completion
Apr 5, 2021
Last update
Dec 19, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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