PSR-SNM

• Research type

  Research Study

• Full title

  Product Surveilence Registry - SNM (Sacral Neuromodulation)

• IRAS ID

  257577

• Contact name

  Charles -H Knowles

• Contact email

  c.h.knowles@qmul.ac.uk

• Sponsor organisation

  Medtronic

• Clinicaltrials.gov Identifier

  NCT01524278, Clinicaltrials.gov

• Duration of Study in the UK

  50 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.
  The registry has been designed as a framework into which individual therapy specific
  investigation 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"
  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 concerns the protocol for patients who have received, or are due to receive Medtronic Neurovascular products used in the treatment overactive bladder, non-obstructive urinary
  retention, and chronic fecal incontinence through direct modulation of the nerve activity.
  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from routine follow-up records until either the sponsor determines that data collection is sufficient, the system is no longer active in the body or the patient is exited for another reason.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 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

  London - City & East Research Ethics Committee

• REC reference

  19/LO/0156

• Date of REC Opinion

  17 Jan 2019

• REC opinion

  Further Information Favourable Opinion