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Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology (ECHOFUSION)

U

University Hospital, Strasbourg, France

Status

Completed

Conditions

Tissular Lesion

Treatments

Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500)

Study type

Interventional

Funder types

Other

Identifiers

NCT02563444
2014-A00413-44

Details and patient eligibility

About

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).

Enrollment

25 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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, ...)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Ultrasound fusion guiding system
Experimental group
Treatment:
Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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