SynchroMed II Post-Approval Study

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00773019
First received: August 21, 2008
Last updated: June 9, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Severe Spasticity
Chronic Pain
Device: Refills (SynchroMed® II Programmable Drug Infusion Pump)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SynchroMed II Programmable Drug Infusion System Post-Approval Study

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize adverse events experienced with the drug infusion system [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: November 2004
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects planning to receive a new or replacement drug pump.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Kelly Wesemann/Principal Clinical Trial Leader, Medtronic Neuromodulation
ClinicalTrials.gov Identifier: NCT00773019     History of Changes
Other Study ID Numbers: 1607
Study First Received: August 21, 2008
Last Updated: June 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
infusion pump
implantable
performance

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014