Medtronic PSR TDD PMCF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-09

Study Completion Date

2024-01-18

Brief Summary

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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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Detailed Description

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

Conditions

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Chronic Pain Spasticity, Muscle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No