SynchroMed II Post-Approval Study
This study has been completed.
First Posted: October 16, 2008
Last Update Posted: June 10, 2009
Information provided by:
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.
|Severe Spasticity Chronic Pain||Device: Refills (SynchroMed® II Programmable Drug Infusion Pump)||Phase 4|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||SynchroMed II Programmable Drug Infusion System Post-Approval Study|
Resource links provided by NLM:
Further study details as provided by MedtronicNeuro:
Primary Outcome Measures:
- 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:
- Characterize adverse events experienced with the drug infusion system [ Time Frame: one year ]
|Study Start Date:||November 2004|
|Study Completion Date:||November 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
No Contacts or Locations Provided