SynchroMed II Post-Approval Study

SynchroMed II Programmable Drug Infusion System Post-Approval Study

NCT00773019•MedtronicNeuro

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Key Dates

Start Date

November 1, 2004

Primary Completion Date

June 1, 2008

Completion Date

November 1, 2008

Last Updated

April 27, 2023

Enrollment

ACTUAL participants

Conditions

Severe SpasticityChronic Pain

Interventions

Refills (SynchroMed® II Programmable Drug Infusion Pump)

DEVICE

Optimization of NIBS for Treatment of Addiction

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Opioid-use DisorderChronic Pain

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RECRUITINGNA

VR Mindfulness Training for Veterans With SCI

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SynchroMed II Post-Approval Study

Inclusion Criteria

Exclusion Criteria

Optimization of NIBS for Treatment of Addiction

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