SynchroMed II Post-Approval Study

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00773019
First received: August 21, 2008
Last updated: June 9, 2009
Last verified: June 2009

August 21, 2008
June 9, 2009
November 2004
June 2008   (final data collection date for primary outcome measure)
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773019 on ClinicalTrials.gov Archive Site
Characterize adverse events experienced with the drug infusion system [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
SynchroMed II Post-Approval Study
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects planning to receive a new or replacement drug pump.

  • Severe Spasticity
  • Chronic Pain
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
November 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00773019
1607
No
Kelly Wesemann/Principal Clinical Trial Leader, Medtronic Neuromodulation
MedtronicNeuro
Not Provided
Not Provided
MedtronicNeuro
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP