SynchroMed II Post-Approval Study

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.

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Key information

Conditions

Severe Spasticity Chronic Pain Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Refills (SynchroMed® II Programmable Drug Infusion Pump)

Device

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.

Primary outcomes

Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed

Time frame: six months

Secondary outcomes

Characterize adverse events experienced with the drug infusion system

Time frame: one year

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

SynchroMed II Programmable Drug Infusion System Post-Approval Study

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Oct 16, 2008
Registry last updated: Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed