Medtronic PSR TDD PMCF

June 3, 2024 updated by: Medtronic

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with SynchroMed II Model 8637 Programmable Pump who meet approved indications (Chronic pain and severe spasticity)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pump accuracy
Time Frame: 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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pump survival
Time Frame: 4 years
Demonstrate pump survival (freedom from product performance events) is > 90 percent at 4 years post-pump implant
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2017

Primary Completion (Actual)

January 18, 2024

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medtronic PSR TDD PMCF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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