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CompletedNCT04714385

Medtronic PSR TDD PMCF

Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)

Status
Completed
Phase
Study type
Observational
Enrollment
209 (actual)
Sponsor
Medtronic · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.

Conditions

Timeline

Start date
2017-02-09
Primary completion
2024-01-18
Completion
2024-01-18
First posted
2021-01-19
Last updated
2024-06-04

Locations

15 sites across 8 countries: Belgium, Czechia, France, Netherlands, Slovenia, Spain, Switzerland, United Kingdom

Source: ClinicalTrials.gov record NCT04714385. Inclusion in this directory is not an endorsement.

Medtronic PSR TDD PMCF (NCT04714385) · Clinical Trials Directory