PSR_Gastric Electrical Stimulation
Research type
Research Study
Full title
PRODUCT SURVEILLANCE REGISTRY (PSR) Gastric Electrical Stimulation (GES)
IRAS ID
240929
Contact name
Sritharan Kadirkamanathan,
Contact email
Sponsor organisation
Medtronic Ltd
Clinicaltrials.gov Identifier
NCT01524276, 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.
The registry is designed to evaluate routine clinical care for Medtronic medical devices, enabling product performance and patient outcomes to be assessed in a "real-life" environment.
The duration of data collection will be determined by the device received by the patient and will be defined within each therapy-specific analysis plan (normally no less than one year and may extend to several years as defined within the therapy analysis plan).
This submission concerns patients who have received, or are due to receive, a Medtronic medical device for the treatment of gastrointestinal conditions. These Medtronic systems are also referred to as gastric neurostimulator systems and components for the treatment of chronic nausea and vomiting associated with gastroparesis.
Following the implant procedure, the patient will be followed up according to standard hospital practise. 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from routine follow- up records until either the sponsor determines that data collection is sufficient, the system is no longer active in the body or the participant is exited from the study (the participant study exit criteria is defined within the study protocol).
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0039
Date of REC Opinion
9 Mar 2018
REC opinion
Further Information Favourable Opinion