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Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
NCT03876054 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Spinal cord stimulation (SCS)
- DEVICE Dorsal root ganglion stimulation (DRG)
Study Locations (20)
California
- California Orthopedics & Spine — Larkspur
- Restore Orthopedics & Spine Center — Orange
- Foothills Pain Management Clinic — Pomona
- Pacific Research Institute — Santa Rosa
Minnesota
- Nura — Edina
- Twin Cities Pain Clinic — Edina
- Mayo Clinic — Rochester
New York
- Ainsworth Institute of Pain Management — New York
- Unity Spine Center — Rochester
- The Spine & Pain Institute of New York — Staten Island
Arizona
- Phoenician Centers for Research & Innovation — Phoenix
- Pain Institute of Southern Arizona — Tucson
Illinois
- Rush University Medical Center — Chicago
- University of Chicago — Chicago
Nevada
- Advanced Pain Care — Henderson
- Nevada Advanced Pain Specialists — Reno
Florida
- University of Florida Department of Anesthesia — Gainesville
Indiana
- Goodman Campbell Brain and Spine — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2029-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03876054
The ClinicalTrials.gov registry entry for NCT03876054 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions — of which Spinal cord stimulation (SCS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03876054 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Minnesota, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03876054 about?
NCT03876054 is a clinical study titled "Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator". 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.
What is the current status of trial NCT03876054?
This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2019-03-13. Estimated completion is 2029-12.
What conditions does trial NCT03876054 study?
This clinical trial studies the following conditions: Chronic Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03876054?
The interventions under investigation include: Spinal cord stimulation (SCS) (DEVICE), Dorsal root ganglion stimulation (DRG) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03876054?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03876054 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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