Medtronic PSR TDD PMCF

Completed

• Conditions: Spasticity, Muscle; Chronic Pain

• Registration Number: NCT04714385
• Lead Sponsor: Medtronic

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 surveillance obligations.

Detailed Description

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

Study Timeline

• Study Start: 2017-02-09
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pump accuracy	4 years	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.

Secondary Outcome Measures

Name	Time	Method
Pump survival	4 years	Demonstrate pump survival (freedom from product performance events) is \> 90 percent at 4 years post-pump implant

Trial Locations

Locations (15)

Middlesbrough; 🇬🇧 Middlesbrough, United Kingdom

Madrid; 🇪🇸 Madrid, Spain

Wilrijk; 🇧🇪 Wilrijk, Belgium

Morges; 🇨🇭 Morges, Switzerland

Brugge; 🇧🇪 Brugge, Belgium

Sint-Niklaas; 🇧🇪 Sint-Niklaas, Belgium

Enschede; 🇳🇱 Enschede, Netherlands

Ljubljana; 🇸🇮 Ljubljana, Slovenia

Maastricht; 🇳🇱 Maastricht, Netherlands

Leuven; 🇧🇪 Leuven, Belgium

Roeselare; 🇧🇪 Roeselare, Belgium

Marseille; 🇫🇷 Marseille, France

Praha; 🇨🇿 Praha, Czechia

Badalona; 🇪🇸 Badalona, Spain

Nottwil; 🇨🇭 Nottwil, Switzerland