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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05707169
Other study ID # R.22.09.1805 - 2022/09/06
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 4, 2023
Est. completion date May 4, 2024

Study information

Verified date January 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

EVLA is used in in treating refluxing veins, commonly the GSV. The tip of catheter is usually placed 2-2.5 cm distal to the sapheno-femoral junction. This technique theoretically provides the lowest risk for endothermal heat-induced thrombosis (EHIT). In the present study we aimed to evaluate the zero-distance technique (the kissing technique) compared to 2-cm distance from SFJ valve in ablating incompetent GSV.


Description:

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Study Design


Intervention

Procedure:
Saphenous Ablation
Endogenous Laser Ablation (EVLA) uses a laser fibre, which is inserted into the refluxing vein via skin puncture.
Device:
Endogenous Laser Ablation (EVLA)
Endogenous Laser Ablation (EVLA)
Drug:
mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline
mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline

Locations

Country Name City State
Egypt Mansoura University Hospital Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence both duplex ultrasound and the clinical examination. A varicose vein that had not been observed before or previously been marked by the patient on the AVVQ form was considered to be a recurrent varicose vein (owing to neo-vascularization or dilation of pre-existing veins). 6 months
Secondary Heat induced thrombosis Duplex Finding of thrombus near saphenofemoral junction 6 months
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