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SynchroMed II Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773019
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : June 10, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Spasticity Chronic Pain Device: Refills (SynchroMed® II Programmable Drug Infusion Pump) Phase 4

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SynchroMed II Programmable Drug Infusion System Post-Approval Study
Study Start Date : November 2004
Primary Completion Date : June 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Intervention Details:
    Device: Refills (SynchroMed® II Programmable Drug Infusion Pump)
    Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump.

Primary Outcome Measures :
  1. Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Characterize adverse events experienced with the drug infusion system [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects planning to receive a new or replacement drug pump.

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

Responsible Party: Kelly Wesemann/Principal Clinical Trial Leader, Medtronic Neuromodulation Identifier: NCT00773019     History of Changes
Other Study ID Numbers: 1607
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009

Keywords provided by MedtronicNeuro:
infusion pump

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms