Venous Malformation
Conditions
Keywords
Foam Sclerotherapy, Ultrasound, Electromagnetic Navigation
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.
Interventions
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.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 time to complete catheterization of the malformation | day 1 | Duration of the procedure. |
| Estimate the undesirable effects associated with assisted electromagnetic navigation. | day 1 | Adverse effects of Electro-Magnetic Navigation. |
Countries
France
Outcome results
None listed