Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

Not Applicable

Completed

• Conditions: Venous Malformation
• Interventions: Device: Electromagnetic Navigation

• Registration Number: NCT04486599
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-09
• Study Start: 2020-07-15
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-24
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electromagnetic Navigation	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

Primary Outcome Measures

Name	Time	Method
Percentage of patients for whom the procedure is successful	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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, Occitanie, France