Skip to content

Medtronic PSR TDD PMCF

CompletedNCT04714385
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

Study details

Official title
Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)
Conditions
Sponsor
Medtronic
Start date
2017-02-09
Primary completion
2024-01-18
Sex
All
Results posted
No results posted in this snapshot
Countries
Belgium, Czechia, France, Netherlands, Slovenia, Spain, Switzerland, United Kingdom
Total sites listed
15

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient or legally authorized representative provides written 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 within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment * The indication for implant meets approved indications * The patient can reasonably be expected to remain fully on label for a 48-month time period after implant Exclusion Criteria: * Patient who is, or will be, inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results * There is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04714385