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OpenTrials
Completed

NCT Number: NCT02563444

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).

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Key information

Conditions

Tissular Lesion Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nouvel Hôpital Civil

Strasbourg, Alsace, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

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

Device

Primary outcomes

  1. 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

  1. 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 frame: time of the procedure

  2. overall satisfaction score

    Time frame: time of the procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ECHOFUSION

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2015
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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