Embolization Coil Systems - Retracta & Hilal - MDR-1912-02
Research type
Research Study
Full title
Embolization Coil Systems Retracta and Hilal \n
IRAS ID
307387
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
22/NS/0051
Date of REC Opinion
12 Apr 2022
REC opinion
Favourable Opinion