SynchroMed II Post-Approval Study

MedtronicNeuro84 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Severe Spasticity Chronic Pain

Interventions

Refills (SynchroMed® II Programmable Drug Infusion Pump)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed

Time frame: six months

Secondary Outcomes

Characterize adverse events experienced with the drug infusion system

Time frame: one year

Data from ClinicalTrials.gov

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