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

December 15, 2025 updated by: University Hospital, Strasbourg, France

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Strasbourg, Alsace, France, 67091
        • Nouvel Hôpital Civil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound fusion guiding system
Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
time of the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
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
time of the procedure
overall satisfaction score
Time Frame: time of the procedure
time of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Afshin GANGI, MD, Strasbourg's University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimated)

September 30, 2015

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00413-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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