Medtronic PSR TDD PMCF

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714385
• Other study ID #: Medtronic PSR TDD PMCF
• Status: Completed
• Start date: February 9, 2017
• Est. completion date: January 18, 2024

Study information

• Verified date: February 2024
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Muscle Spasticity
• Spasticity, Muscle

Locations

Country	Name	City	State
Belgium	Brugge	Brugge
Belgium	Leuven	Leuven
Belgium	Roeselare	Roeselare
Belgium	Sint-Niklaas	Sint-Niklaas
Belgium	Wilrijk	Wilrijk
Czechia	Praha	Praha
France	Marseille	Marseille
Netherlands	Enschede	Enschede
Netherlands	Maastricht	Maastricht
Slovenia	Ljubljana	Ljubljana
Spain	Badalona	Badalona
Spain	Madrid	Madrid
Switzerland	Morges	Morges
Switzerland	Nottwil	Nottwil
United Kingdom	Middlesbrough	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Netherlands,  Slovenia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pump accuracy	Demonstrate that the proportion of subjects treated as intended (p) with flow rate accuracy outside the interval of 0.75 to 1.25 (±25 percent) is < 10 percent with 95 percent confidence at 4 years post implant.	4 years
Secondary	Pump survival	Demonstrate pump survival (freedom from product performance events) is > 90 percent at 4 years post-pump implant	4 years