RecruitingNCT03876054
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Sponsor
Abbott Medical Devices
Enrollment
2,000 participants
Start Date
Mar 13, 2019
Study Type
OBSERVATIONAL
Conditions
Summary
The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
- Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
Exclusion Criteria5
- Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Subject has or is scheduled to receive an intrathecal pump.
- Subject is part of a vulnerable population.
- Subject has an existing implanted neuromodulation device to address their chronic pain.
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Interventions
DEVICESpinal cord stimulation (SCS)
Subjects will be implanted with market-released Abbott SCS systems
DEVICEDorsal root ganglion stimulation (DRG)
Subjects will be implanted with market-released Abbott DRG system
Locations(55)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03876054
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