Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electromagnetic Navigation | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the number of punctures required to achieve catheterization of the malformation. | Number of percutaneous punctures needed to obtain vascular backflow. | day 1 |
| Estimate the time to complete catheterization of the malformation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wassim Mokaddem, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Toulouse | Occitanie | 31059 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Duration of the procedure.
| day 1 |
| Estimate the undesirable effects associated with assisted electromagnetic navigation. | Adverse effects of Electro-Magnetic Navigation. | day 1 |