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OpenTrials
Completed

NCT Number: NCT04714385

Medtronic PSR TDD 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.

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Key information

Conditions

Chronic Pain Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle

Sex eligibility

All sexes

Study type

Observational

Primary location

Brugge, Bruges, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pump survival

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2021
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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