Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.

Conditions
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Venous Malformation

Intervention / Treatment
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* Device: Electromagnetic Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electromagnetic Navigation<br>The patient have to low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI. Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting | Device: Electromagnetic Navigation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the number of punctures required to achieve catheterization of the malformation. | Number of percutaneous punctures needed to obtain vascular backflow. | day 1 | 
| Estimate the time to complete catheterization of the malformation | Duration of the procedure. | day 1 | 
| Estimate the undesirable effects associated with assisted electromagnetic navigation. | Adverse effects of Electro-Magnetic Navigation. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foam Sclerotherapy, Ultrasound, Electromagnetic Navigation