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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