Ablation Clinical Trial
Official title:
Multicentric Evaluation of IMACTIS-CT Navigation System
Verified date | December 2017 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 464 |
Est. completion date | September 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Besançon | Doubs |
France | University Hospital | Bordeaux | Gironde |
France | Ambroise Paré University Hospital | Boulogne Billancourt | Hauts-de-Seine |
France | University Hospital | Grenoble | Isère |
France | University Hospital | Lille | Nord |
France | University Hospital | Nancy | Meuse |
France | University Hospital of Saint-Louis | Paris | |
France | University Hospital | Rennes | Ille-et-Vilaine |
France | University Hospital | Tours | Indre-et-Loire |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 interventional radiology gestures | Three criteria are estimated: Safety: number of major complications (due to gesture) Efficiency: number of targets achieved Performance: number of scancontrol made during the puncture |
2 hours | |
Secondary | Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method. | 2 hours | ||
Secondary | Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture. | Scale of quantitative satisfaction | 2 hours | |
Secondary | Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture. | 2 hours | ||
Secondary | Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture | 2 hours | ||
Secondary | Evaluation of the navigation system use by the operators, based on needle holder localization files | 2 hours |
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