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Long-term Surveillance of the MedStream Programmable Infusion System

NCT01712087 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2019-01-23

No results posted yet for this study

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

DEVICE

MedStream Programmable Infusion System

Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Sponsors & Collaborators

  • Codman & Shurtleff

    lead INDUSTRY

Principal Investigators

  • Jonathan T Megerian, MD · Codman & Shurtleff

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-01
Primary Completion
2017-12-17
Completion
2017-12-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712087 on ClinicalTrials.gov