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Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial

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  • معلومة اضافية
    • Contributors:
      Centre d'Investigation Clinique - Innovation Technologique - INSERM - CHU de Grenoble (CIC-IT Grenoble (CIT803)); Centre Hospitalier Universitaire CHU Grenoble (CHUGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA); Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG); Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes 2016-2019 (UGA 2016-2019 ); Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon); Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux); CIC Bordeaux; Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM); Hôpital Ambroise Paré AP-HP; Centre d’Investigation Clinique 1429 Garches (CIC 1429); Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Hôpital Raymond Poincaré AP-HP -Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy); Centre d'investigation clinique Nancy (CIC); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre d'Investigation Clinique Rennes (CIC); Université de Rennes (UR)-Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou -Institut National de la Santé et de la Recherche Médicale (INSERM); CHU Trousseau Tours; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Centre d’Investigation Clinique Tours CIC 1415 (CIC); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Institut National de la Santé et de la Recherche Médicale (INSERM); Hopital Saint-Louis AP-HP (AP-HP); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Service central de radiologie et d'imagerie médicale; Centre Hospitalier Universitaire CHU Grenoble (CHUGA)-Hôpital Michallon; This trial is funded by the French Ministry of Health as part of the Hospital Clinical Research Program (PHRC-N 2012).
    • بيانات النشر:
      CCSD
      BioMed Central
    • الموضوع:
      2017
    • Collection:
      LillOA (HAL Lille Open Archive, Université de Lille)
    • نبذة مختصرة :
      International audience ; BACKGROUND: Interventional radiology includes a range of minimally invasive image-guided diagnostic and therapeutic procedures that have become routine clinical practice. Each procedure involves a percutaneous needle insertion, often guided using computed tomography (CT) because of its availability and usability. However, procedures remain complicated, in particular when an obstacle must be avoided, meaning that an oblique trajectory is required. Navigation systems track the operator's instruments, meaning the position and progression of the instruments are visualised in real time on the patient's images. A novel electromagnetic navigation system for CT-guided interventional procedures (IMACTIS-CT®) has been developed, and a previous clinical trial demonstrated improved needle placement accuracy in navigation-assisted procedures. In the present trial, we are evaluating the clinical benefit of the navigation system during the needle insertion step of CT-guided procedures in the thoraco-abdominal region.METHODS/DESIGN: This study is designed as an open, multicentre, prospective, randomised, controlled interventional clinical trial and is structured as a standard two-arm, parallel-design, individually randomised trial. A maximum of 500 patients will be enrolled. In the experimental arm (navigation system), the procedures are carried out using navigation assistance, and in the active comparator arm (CT), the procedures are carried out with conventional CT guidance. The randomisation is stratified by centre and by the expected difficulty of the procedure. The primary outcome of the trial is a combined criterion to assess the safety (number of serious adverse events), efficacy (number of targets reached) and performance (number of control scans acquired) of navigation-assisted, CT-guided procedures as evaluated by a blinded radiologist and confirmed by an expert committee in case of discordance. The secondary outcomes are (1) the duration of the procedure, (2) the satisfaction of the operator ...
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/28683837; PUBMED: 28683837
    • الرقم المعرف:
      10.1186/s13063-017-2049-6
    • الدخول الالكتروني :
      https://univ-rennes.hal.science/hal-01560366
      https://univ-rennes.hal.science/hal-01560366v1/document
      https://univ-rennes.hal.science/hal-01560366v1/file/Rouchy%20-%20Evaluation%20of%20the%20clinical%20benefit.pdf
      https://doi.org/10.1186/s13063-017-2049-6
    • Rights:
      info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.2533951B