Status:
COMPLETED
Medtronic PSR TDD PMCF
Lead Sponsor:
Medtronic
Conditions:
Chronic Pain
Spasticity, Muscle
Eligibility:
All Genders
Brief 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 survei...
Detailed Description
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT04714385
Start Date
February 9 2017
End Date
January 18 2024
Last Update
June 4 2024
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Brugge
Bruges, Belgium
2
Leuven
Leuven, Belgium
3
Roeselare
Roeselare, Belgium
4
Sint-Niklaas
Sint-Niklaas, Belgium