SynchroMed II Post-Approval Study

April 25, 2023 updated by: MedtronicNeuro

SynchroMed II Programmable Drug Infusion System Post-Approval Study

This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

84

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects planning to receive a new or replacement drug pump.

Description

Inclusion Criteria:

  • Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
  • Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
  • Be geographically stable and willing to return to the study center for follow-up visits
  • Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
  • Age is at least 18 years of age at time of enrollment

Exclusion Criteria:

  • Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
  • Have an ongoing infection prior to implant
  • Have insufficient body mass to accept the pump bulk and weight
  • Are unable or unwilling to adhere to the study protocol
  • Have an estimated life expectancy of less than twelve months

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
Time Frame
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize adverse events experienced with the drug infusion system
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

MedtronicNeuro

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

November 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1607

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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Locations

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