SynchroMed II Post-Approval Study

SynchroMed II Programmable Drug Infusion System Post-Approval Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00773019

Enrollment

Registered

2008-10-16

Start date

2004-11-30

Completion date

2008-11-30

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Severe Spasticity

Keywords

infusion pump, implantable, performance

Brief 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.

Interventions

DEVICERefills (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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed	six months

Secondary

Measure	Time frame
Characterize adverse events experienced with the drug infusion system	one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026