Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology

Not Applicable

Completed

• Conditions: Tissular Lesion
• Interventions: Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500)

• Registration Number: NCT02563444
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-09
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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, ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound fusion guiding system	Ultrasound fusion guiding system - TUS A-500 (Aplio 500)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
overall satisfaction score	time of the procedure
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

Trial Locations

Locations (1)

Nouvel Hôpital Civil; 🇫🇷 Strasbourg, Alsace, France