PSR-NV
Research type
Research Study
Full title
Product Surveillance Registry - NeuroVascular
IRAS ID
220323
Contact name
Saleh Lamin
Contact email
Sponsor organisation
Medtronic
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
The Product Surveillance Registry (PSR)involves patients who have received a Medtronic product as part of their standard clinical management. Ultimately, a wide range of patient groups are to be studied across diabetes, cardiac rhythm disorders, spinal, orthopaedic, urological, gastrointestinal, neurological, ear/nose/throat and cardiovascular conditions.\nThe registry has been designed as a framework into which individual therapy specific\ninvestigation plans will be incorporated, indefinitely, over time. Within this framework, participants are to be managed as per routine care, enabling product performance and patient outcomes to be assessed in a “real-life“\nenvironment. The duration of data collection will be determined by the product received by the patient, but will normally be no less than one year and may extend to several years as defined within each therapy specific investigation plan.\nThe current submission concerns the protocol for patients who have received, or are due to receive Medtronic NeuroVascular products used in the treatment of Intra-cranial aneurysms (IAs) including: Flow Diverters, Intra saccular devices or Vascular Reconstruction Devices.\nFollowing the implant procedure, the patient will return for clinic visits\naccording to the hospital schedule. Registry data will be derived from routine follow-up records until either the sponsor determines that data collection is sufficient, the system is no longer active in the body or the patient is exited for another reason. The incorporation of additional therapies into the registry over time will create an extensive repository of data to serve as a source of information relating to acute and chronic product performance, patient safety and clinical outcomes. Such data may assist with the early detection of performance issues and help to define patient outcomes with the aim of creating benefits for patients through future advances in technology and condition management
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0078
Date of REC Opinion
18 Jan 2017
REC opinion
Favourable Opinion