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โ† Trials
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Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Recruitingn/aAges 18 Years - anyAllAbbott Medical Devices
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation related procedure. 2. 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. 3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline. 4. Subject has a baseline (with no stimulation) pain NRS of โ‰ฅ 6. Exclusion Criteria: 1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott. 2. 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. 3. Subject has or is scheduled to receive an intrathecal pump. 4. Subject is part of a vulnerable population. 5. Subject has an existing implanted neuromodulation device to address their chronic pain.
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What it tests

  • Spinal cord stimulation (SCS)
  • Dorsal root ganglion stimulation (DRG)
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Where

55 sites
Phoenician Centers for Research & Innovation
Phoenix, United States
Pain Institute of Southern Arizona
Tucson, United States
California Orthopedics & Spine
Larkspur, United States
Restore Orthopedics & Spine Center
Orange, United States
Foothills Pain Management Clinic
Pomona, United States
Pacific Research Institute
Santa Rosa, United States
University of Florida Department of Anesthesia
Gainesville, United States
Rush University Medical Center
Chicago, United States

โ€ฆand 47 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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