SynchroMed II Post-Approval Study
CompletedNCT00773019
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- SynchroMed II Programmable Drug Infusion System Post-Approval Study
- Conditions
- Severe Spasticity
- Chronic Pain
- Interventions
- Device: Refills (SynchroMed® II Programmable Drug Infusion Pump)
- Sponsor
- MedtronicNeuro
- Start date
- 2004-11
- Primary completion
- 2008-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00773019