This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.
Study Type
OBSERVATIONAL
Enrollment
2
Intrathecal Infusion of Baclofen in the Treatment of Spasticity
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Methodist Hospital Research Institute
Houston, Texas, United States
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit
Time frame: 24 Months
MedStream system-related AEs occurring from 24 to 36 months
Time frame: 36 Months
Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.
Device-related AEs occurring in subjects with both MedStream and non-MedStream devices used or implanted during the course of the study. Device refers to the pump and intrathecal catheters
Time frame: 24 Months
Procedure-related AEs
Procedure-related AEs including, but not limited to the following study procedures: MedStream system implant, pump refill and bolus, and reprogramming. If non-MedStream devices or components are utilized in these procedures, this will be described.
Time frame: 24 Months
Drug-related AEs associated with intrathecal Baclofen
Time frame: 24 Months
Drug-related AEs associated with other intrathecally-administered medications
Time frame: 24 Months
Disease-related AEs associated with pre-existing conditions
Disease-related AEs associated with pre-existing conditions that demonstrate a significant worsening of the disease or an increase in the frequency of episodes since baseline, as determined by the investigator.
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Time frame: 24 Months
Serious Adverse Events (SAEs)
Time frame: 36 Months
Unanticipated Adverse Device Effects (UADEs)
Time frame: 24 Months
The secondary effectiveness endpoints will be long-term effectiveness of MedStream System
Long-term effectiveness as demonstrated by scores on the Ashworth Scale (lower extremity) and the frequency and severity components of the Penn Spasm Frequency Scale (PSFS) measured pre-implant, post-implant and at each of the protocol-specified study visits.
Time frame: 24 Month