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COMPLETEDNCT00773019

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...

Lead sponsor: MedtronicNeuro•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

MedtronicNeuro

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 27, 2023Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment84

Start dateNov 2004

Last updatedApr 27, 2023

Condition

Severe Spasticity Chronic Pain

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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: May 25, 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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