Product Surveillance Registry Base Protocol, Version 2.
Research type
Research Study
Full title
Product Surveillance Registry - A prospective, non-interventional registry providing continuing evaluation and periodic reporting of product safety, effectiveness and patient outcomes across Medtronic market-released products within diabetes, cardiac rhythm disorders, urological, gastrointestinal, spinal, orthopaedic, neurological and ear nose and throat conditions.
IRAS ID
100377
Contact name
Nicholas J Linker
Contact email
Sponsor organisation
Medtronic Inc. c/o Medtronic Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
75 years, 0 months, 0 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.
The registry has been designed as a framework, entitled the "Base Protocol", comprising minimum standards and criteria into which individual therapy-specific investigation plans will be incorporated, indefinately, over time. Within this framework, participants are to be managed under routine care, enabling product performance and patient outcomes to be assessed in a "real-life" environment. 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.
The current submission includes the overall Base Protocol for the registry and additionally the protocol for patients who have received, or are due to receive, a Medtronic cardiac rhythm management system or Medtronic component of such a system. Following the implant procedure, the patient will return for clinic visits according 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from routine follow-up records until either the sponsor determines that data collection is sufficient, the system is no longer active in the body, or the patient is exited for another reason.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 different therapies into the registry over time will create 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 product 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 East - York Research Ethics Committee
REC reference
13/NE/0005
Date of REC Opinion
25 Feb 2013
REC opinion
Further Information Favourable Opinion