Status:
RECRUITING
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Lead Sponsor:
Abbott Medical Devices
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Brief 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 population...
Detailed Description
This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03876054
Start Date
March 13 2019
End Date
December 1 2029
Last Update
January 7 2026
Active Locations (55)
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1
Phoenician Centers for Research & Innovation
Phoenix, Arizona, United States, 85021
2
Pain Institute of Southern Arizona
Tucson, Arizona, United States, 85718
3
California Orthopedics & Spine
Larkspur, California, United States, 94939
4
Restore Orthopedics & Spine Center
Orange, California, United States, 92868