PSRP Platform Base - Product Surveillance Registry

Overview

About this study

The purpose of the Patient Surveillance Registry is to serve as an ongoing source of product performance, patient safety and clinical outcomes information associated with the use of market-released products.
 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements,
  • Patient has, or is intended to receive or be treated with, an eligible Medtronic product.
  • Patient is consented within the enrollment window of the therapy received, as applicable Additional criteria may be required, refer to Condition/Therapy Appendix for further guidance.

Exclusion Criteria:

  • Patient who is, or is expected to be, inaccessible for follow-up.
  • Patient is excluded by local law.
  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results (i.e., no required intervention that could affect interpretation of allaround product safety and/or effectiveness).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/31/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Morris, M.D.

Open for enrollment

Contact information:

Desirae Howe-Clayton

(507) 255-0111

Howe.Desirae@mayo.edu

More information

Publications

Publications are currently not available