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

Liver Biopsy Clinical Trial

— IFE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02573545
• Other study ID #: 5261
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2017

Study information

• Verified date: October 2015
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Biopsy

Intervention

Device:
• Planning@IFE and Standard@IFE Software

• MR Syngo (Numaris/4) software

Locations

Country	Name	City	State
France	Nouvel Hôpital civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration of the intervention (planning and implementation)		up to 2 weeks