Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations
- Conditions
- Venous Malformation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
- Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
- 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
- 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.
Related Research Topics
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Trial Locations
- Locations (1)
University Hospital
🇫🇷Toulouse, Occitanie, France
University Hospital🇫🇷Toulouse, Occitanie, France