NCT00773019

SynchroMed II Post-Approval Study

SynchroMed II Programmable Drug Infusion System Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Severe Spasticity
• Chronic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-06-01
• Completion: 2008-11-01
• First posted: 2008-10-16
• Last updated: 2023-04-27