A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy
NCT ID: NCT02349646
Last Updated: 2019-10-16
Study Results
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View full resultsBasic Information
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TERMINATED
33 participants
OBSERVATIONAL
2013-04-25
2016-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treated subjects
All subjects recruited and treated with the Axium neurostimulator
Implantation with the commercially available Axium neurostimulator
Interventions
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Implantation with the commercially available Axium neurostimulator
Eligibility Criteria
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Inclusion Criteria
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Peripheral neuropathy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. Subject is able to provide written informed consent
Exclusion Criteria
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
5. Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
9. Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Heinrich Heine Universität Düsseldorf
Düsseldorf, , Germany
Countries
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Other Identifiers
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10-SMI-2012
Identifier Type: -
Identifier Source: org_study_id
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