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Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case (IFE)

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: NCT02573545
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : October 9, 2015
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 9, 2015
Last Update Posted Date December 4, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
Total duration of the intervention (planning and implementation) [ Time Frame: up to 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
Official Title  ICMJE Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
Brief Summary

To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:

  • a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
  • a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Liver Biopsy
Intervention  ICMJE
  • Device: Planning@IFE and Standard@IFE Software
  • Device: MR Syngo (Numaris/4) software
Study Arms  ICMJE
  • Experimental: Test group: with IFE
    Patients treated with IFE software
    Intervention: Device: Planning@IFE and Standard@IFE Software
  • Active Comparator: Test group: without IFE
    Patients treated with Numaris 4 software
    Intervention: Device: MR Syngo (Numaris/4) software
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 8, 2015)
148
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is at least 18 years old
  • Affiliated to a social security scheme
  • Informed consent
  • Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI

Exclusion Criteria:

  • Patient with a contraindication for MRI exam
  • Patient with a contraindication for performing a biopsy
  • Pregnancy
  • Exclusion period
  • Patient unable to receive and understand information about the study
  • Patients under guardianship
  • Patients under judicial protection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02573545
Other Study ID Numbers  ICMJE 5261
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Strasbourg, France
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP