Status:
COMPLETED
SynchroMed II Post-Approval Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Severe Spasticity
Chronic Pain
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00773019
Start Date
November 1 2004
End Date
November 1 2008
Last Update
April 27 2023
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