CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Ablation; Punction; Biopsy; Drainage

Treatments: Device: CT; Device: Navigation station (IMACTIS-CT®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01896219

DCIC 12 29

2013-A00539-36 (Other Identifier)

Details and patient eligibility

About

Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of interventional radiology under scan in the thoraco-abdominal level.

Enrollment: 464 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• More or equal the 18 years old
• Patient for whom an indication of diagnostic or therapeutic percutaneous interventional gesture in the thoraco-abdominal level under CT guidance is prescribed
• Patient affiliated to social security or similarly regime
• Patient signed consent for participation in the study.

Exclusion criteria

• Patient with a medical device using a magnetic field (eg, patient with a pacemaker)
• Patient who presents ferromagnetic foreign bodies intracorporeal close to the working zone of Radiologist, and that can interact with the medical device
• Pregnant women and lactating mothers
• Ward of court or under guardianship
• Person deprived of freedom by judicial or administrative decision
• Person under legal protection

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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464 participants in 2 patient groups

Gesture performed under control tomodensitometric (CT)

Active Comparator group

Description:

Conventional

Treatment:

Device: CT

Gesture performed under Navigation-assisted procedure (NAV)

Experimental group

Description:

Use of the IMACTIS-CT® Navigation System

Treatment:

Device: Navigation station (IMACTIS-CT®)