Long-term Surveillance of the MedStream Programmable Infusion System
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|ClinicalTrials.gov Identifier: NCT01712087|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : October 23, 2012
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment|
|Spasticity||Device: MedStream Programmable Infusion System|
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity|
|Actual Study Start Date :||October 1, 2012|
|Actual Primary Completion Date :||December 17, 2017|
|Actual Study Completion Date :||December 17, 2017|
MedStream System Implants
All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen.
Device: MedStream Programmable Infusion System
Intrathecal Infusion of Baclofen in the Treatment of Spasticity
- The primary endpoint is the incidence of MedStream system-related Adverse Events (AE) [ Time Frame: 24 Months ]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
- 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. [ Time Frame: 24 Months ]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
- Procedure-related AEs [ Time Frame: 24 Months ]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.
- 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 [ Time Frame: 24 Months ]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.
- 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 [ Time Frame: 24 Month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712087
|United States, Massachusetts|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Texas|
|Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|Study Director:||Jonathan T Megerian, MD||Codman & Shurtleff|