SynchroMed II Post-Approval Study
Completed
- Conditions
- Severe SpasticityChronic Pain
- Registration Number
- NCT00773019
- Lead Sponsor
- MedtronicNeuro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed six months
- Secondary Outcome Measures
Name Time Method Characterize adverse events experienced with the drug infusion system one year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of action for drug infusion systems in managing severe spasticity and chronic pain?
How does the SynchroMed II system compare to standard-of-care treatments for spasticity and chronic pain in terms of effectiveness and safety?
What biomarkers are associated with optimal patient selection for drug infusion therapy in severe spasticity and chronic pain conditions?
What are the most common adverse events reported in post-approval studies of programmable drug infusion systems like the SynchroMed II?
Are there any combination therapies or competitor devices for chronic pain management that show comparable outcomes to the SynchroMed II system?