Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

University Hospital, Toulouse30 enrolled

Overview

The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.

Primary interventional treatment of low flow vascular anomalies includes ultrasound guided foam sclerotherapy. Each procedure involves a percutaneous needle insertion. However, procedures remain complicated to obtain the right trajectory in order to inject the foam at the center of the abnormality. Electromagnetic navigation system tracks the operator's needle, meaning the position and progression of the needle is visualized in 3D real time on the ultrasound probe interface. The present trial evaluate the feasibility of the electromagnetic navigation system during the needle insertion and the improvement of needle placement accuracy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Malformation

Interventions

Electromagnetic NavigationDEVICE

The echo-guided sclerotherapy procedure, assisted by electromagnetic navigation, will be carried out in a clean room during the day hospitalisation and followed by a control Echo-Doppler carried out 2 hours after the procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI * Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting Exclusion Criteria: * patients with pacemakers or internal defibrillator * patients with ferromagnetic implanted material * patients who are wards of court or under guardianship * patients deprived of freedom by judicial or administrative decision * patients under legal protection * pregnant women

Locations (1)

University Hospital

Toulouse, Occitanie, France

Outcomes

Primary Outcomes

Percentage of patients for whom the procedure is successful

Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.

Time frame: day 1

Secondary Outcomes

Estimate the number of punctures required to achieve catheterization of the malformation.

Number of percutaneous punctures needed to obtain vascular backflow.

Time frame: day 1

Estimate the time to complete catheterization of the malformation

Duration of the procedure.

Time frame: day 1

Estimate the undesirable effects associated with assisted electromagnetic navigation.

Adverse effects of Electro-Magnetic Navigation.

Time frame: day 1

Data from ClinicalTrials.gov

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