SynchroMed II Post-Approval Study

NCT00773019 | Completed

• 1 other identifier: 1607
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Spasticity; Chronic Pain

Keywords

infusion pump; implantable; performance

Outcome Measures

Primary Outcomes (1)

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

  six months

Secondary Outcomes (1)

• Characterize adverse events experienced with the drug infusion system

  one year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects planning to receive a new or replacement drug pump.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

MeSH Terms

Conditions

Muscle Spasticity; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: October 16, 2008
• Study Start: November 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 27, 2023

Record last verified: 2023-04