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Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Varicose Vein

NCT05707169 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-01-31

No results posted yet for this study

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.

Conditions

  • Varicose Veins
  • Venous Reflux
  • Venous Insufficiency
  • Venous Leg Ulcer

Interventions

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2024-02-04
Completion
2024-05-04

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05707169 on ClinicalTrials.gov