SynchroMed II Post-Approval Study

Chronic Pain Clinical Trial

Official title:

SynchroMed II Programmable Drug Infusion System Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773019
• Other study ID #: 1607
• Status: Completed
• Start date: November 2004
• Est. completion date: November 2008

Study information

• Verified date: April 2023
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
• Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
• Be geographically stable and willing to return to the study center for follow-up visits
• Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
• Age is at least 18 years of age at time of enrollment

Exclusion Criteria:

• Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
• Have an ongoing infection prior to implant
• Have insufficient body mass to accept the pump bulk and weight
• Are unable or unwilling to adhere to the study protocol
• Have an estimated life expectancy of less than twelve months

Related Conditions & MeSH terms

• Chronic Pain
• Severe Spasticity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed		six months
Secondary	Characterize adverse events experienced with the drug infusion system		one year