NCT01712087

Long-term Surveillance of the MedStream Programmable Infusion System

Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spasticity

Interventions

Type	Name	Description
DEVICE	MedStream Programmable Infusion System	Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-12-17
• Completion: 2017-12-17
• First posted: 2012-10-23
• Last updated: 2019-01-23

Locations

2 sites across 1 country: United States