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Medtronic PSR TDD PMCF

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

NCT04714385•Medtronic

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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 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

Locations (15)

Brugge

Bruges, Belgium

Leuven

Leuven, Belgium

Roeselare

Roeselare, Belgium

Sint-Niklaas

Sint-Niklaas, Belgium

Wilrijk

Wilrijk, Belgium

Praha

Prague, Czechia

Marseille

Marseille, France

Enschede

Enschede, Netherlands

Maastricht

Maastricht, Netherlands

Ljubljana

Ljubljana, Slovenia

Key Dates

Start Date

February 9, 2017

Primary Completion Date

January 18, 2024

Completion Date

January 18, 2024

Last Updated

June 4, 2024

Enrollment

209

ACTUAL participants

Conditions

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Medtronic PSR TDD PMCF

Inclusion Criteria

Exclusion Criteria

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