Tissular Lesion Clinical Trial
— ECHOFUSIONOfficial title:
Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in
the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by
comparing the path indicated by the ultrasound fusion (virtual line) and the path actually
obtained on the control CT scan (real line).
Compared with ultrasound guidance alone or CT scan alone, the results are expected to be
more accurate, saving time and irradiation (not evaluated here).
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | September 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - age>18 years - male or female - women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual - Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ - patient signed an informed consent Exclusion Criteria: - Contraindications to the use of X-rays (pregnancy) - Patients using vital electronic devices (eg: pacemaker or defibrillator) - Subject under judicial protection - Subject under tutorship or curatorship - Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Nouvel Hôpital Civil | Strasbourg | Alsace |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed) | time of the procedure | No | |
| Secondary | distance between the center of the target and the extension of the spinal needle (perpendicular line to this projection through the center of the lesion) | time of the procedure | No | |
| Secondary | overall satisfaction score | time of the procedure | No |