Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
RecruitingNCT03876054
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
- Conditions
- Interventions
- Device: Spinal cord stimulation (SCS)
- Device: Dorsal root ganglion stimulation (DRG)
- Sponsor
- Abbott Medical Devices
- Start date
- 2019-03-13
- Primary completion
- 2029-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia, Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
- Total sites listed
- 55
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 ≥ 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03876054