Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

NCT ID: NCT04486599

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-05-12

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.

Conditions

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Venous Malformation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electromagnetic Navigation

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

Group Type EXPERIMENTAL

Electromagnetic Navigation

Intervention Type DEVICE

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.

Interventions

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Electromagnetic Navigation

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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wassim Mokaddem, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital

Toulouse, Occitanie, France

Site Status

Countries

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France

Other Identifiers

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RC31/19/0516

Identifier Type: -

Identifier Source: org_study_id

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