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OpenTrials
Completed

NCT Number: NCT04486599

Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

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.

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Key information

Conditions

Venous Malformation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, Occitanie, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electromagnetic Navigation

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.

Primary outcomes

  1. Percentage of patients for whom the procedure is successful

    Time frame: day 1

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

Secondary outcomes

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

    Time frame: day 1

    Number of percutaneous punctures needed to obtain vascular backflow.

  2. Estimate the time to complete catheterization of the malformation

    Time frame: day 1

    Duration of the procedure.

  3. Estimate the undesirable effects associated with assisted electromagnetic navigation.

    Time frame: day 1

    Adverse effects of Electro-Magnetic Navigation.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: SCLERONAV

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2020
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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