Embolization Coil Systems - Retracta & Hilal - MDR-1912-02

  • Research type

    Research Study

  • Full title

    Embolization Coil Systems Retracta and Hilal \n



  • Contact name

    Jowad Raja

  • Contact email


  • Sponsor organisation

    Cook Research Incorporated

  • Duration of Study in the UK

    0 years, 8 months, 1 days

  • Research summary

    This is a retrospective, observational, single-arm post-market study that will be performed to collect patient-level data on the Cook Incorporated Retracta® Detachable Embolization Coil systems and the William Cook Europe Hilal Microcoils™ Embolization Coil systems. \nThis data collection effort is expected to be completed within 15 months of study initiation. Each site will complete patient enrollment within a period of five months. Eligible patient data will be reviewed for all available study-related information through 30 days after the first embolization procedure and entered into study-specific electronic case report forms (eCRFs). The general data to be collected, as available at each clinical site for eligible study patients, will include basic demographic data (age at procedure and sex) and relevant past or current medical conditions, procedure data, and any adverse event data. The data extracted will be from procedures occurring between 01 January 2018 and 31 December 2020.

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference


  • Date of REC Opinion

    12 Apr 2022

  • REC opinion

    Favourable Opinion

Shape the future of the HRA website.