Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Spinal cord stimulation (SCS)
- Dorsal root ganglion stimulation (DRG)
Treatment groups
2,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov