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SynchroMed II Post-Approval Study

NCT00773019 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2023-04-27

No results posted yet for this study

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 treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.

Conditions

Interventions

DEVICE

Refills (SynchroMed® II Programmable Drug Infusion Pump)

Refill information at 1, 6, and 12 months post-implant, as well as any additional refills required from implant through end of study. Amount removed from the pump (taken from syringe), Amount placed in the pump (from syringe),Pump predicted amount remaining in the pump.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-06-30
Completion
2008-11-30

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Entities

Diseases

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 NCT00773019 on ClinicalTrials.gov