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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563444
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Tissular Lesion Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
Study Start Date : June 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563444


Locations
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France
Nouvel Hôpital Civil
Strasbourg, Alsace, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Afshin GANGI, MD Strasbourg's University Hospitals
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02563444    
Other Study ID Numbers: 2014-A00413-44
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Strasbourg, France:
Diagnostic (Biopsy) or Therapeutic Procedure (Infiltration, Ablation)