Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Launched by ABBOTT MEDICAL DEVICES · Mar 13, 2019

Keywords

ClinConnect Summary

The REALITY study is looking at how well Abbott's neurostimulation systems work for people suffering from chronic pain. This research aims to gather information about the safety and effectiveness of these devices over time. If you are at least 18 years old, have a pain level of 6 or higher on a scale of 0 to 10, and are scheduled to have one of these neurostimulators implanted within the next two months, you may be eligible to participate.

Participants in this study will be asked to provide consent to join and will be monitored to see how the neurostimulator helps with their pain over both short and long periods. It's important to note that individuals with certain medical conditions or those already involved in other clinical studies may not qualify for this trial. Overall, this study aims to provide valuable insights for people dealing with chronic pain and how this treatment can impact their lives.

Gender

ALL

Eligibility criteria

• 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.