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Clinical Trials/NCT02563444
NCT02563444
Completed
Not Applicable

Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology

University Hospital, Strasbourg, France1 site in 1 country25 target enrollmentJune 1, 2014
ConditionsTissular Lesion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tissular Lesion
Sponsor
University Hospital, Strasbourg, France
Enrollment
25
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
4 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 1, 2014
End Date
September 1, 2015
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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, ...)

Outcomes

Primary Outcomes

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 Frame: time of the procedure

Secondary Outcomes

  • 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)

Study Sites (1)

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