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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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02573545
Acronym
IFE
Enrollment
148
Registered
2015-10-09
Start date
2013-01-31
Completion date
2017-10-31
Last updated
2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Biopsy

Keywords

liver

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

Interventions

DEVICEPlanning@IFE and Standard@IFE Software
DEVICEMR Syngo (Numaris/4) software

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total duration of the intervention (planning and implementation)up to 2 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026