An observational study in Severe Spasticity and Chronic Pain, sponsored by MedtronicNeuro. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by MedtronicNeuro · Observational
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 84 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →MedtronicNeuro is the lead sponsor of 69 studies on the registry; 2 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects planning to receive a new or replacement drug pump.
Exclusion Criteria:
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.
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed
Time frame: six months
Characterize adverse events experienced with the drug infusion system
Time frame: one year
No study locations are listed for this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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MedtronicNeuro