Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

Venous Malformation Clinical Trial

— SCLERONAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486599
• Other study ID #: RC31/19/0516
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: May 12, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Venous Malformation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	University Hospital	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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