PSR Surgical Base
Research type
Research Study
Full title
Surgical Product Surveillance Registry (PSR) platform base clinical investigation plan Dextile™ Anatomical Mesh Addendum
IRAS ID
287141
Contact name
Ruben Larue
Contact email
Sponsor organisation
Medtronic ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
75 years, 0 months, 1 days
Research summary
The PSR registry is an ongoing record of the experience from people around the world treated with a Medtronic product and its performance. It will be used to support post-market surveillance activities and post-approval studies, e.g. to collect safety and performance information as required by regulations applicable to Medtronic. In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research.
The registry is not an experimental clinical study. For this registry, we will only be collecting data, assessed in a "real-life" environment and therefore the duration of data collection will be determined by the product received by the patient.
This submission is for patients who have been, or are due to be, treated with a Medtronic market-approved surgical product (PSR Surgical Base CIP).
The first accompanying addendum for the surgical base protocol is for the Dextile™ Anatomical Mesh, to assess its safety and performance in the 24 months following an inguinal hernia repair.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0125
Date of REC Opinion
30 Sep 2021
REC opinion
Further Information Favourable Opinion