Long-Term Real-World Study on Safety and Effectiveness of Abbott Neurostimulation Systems for Chronic Pain

What this Trial Is About

Researchers are investigating the long-term safety and effectiveness of Abbotts neurostimulation systems in people with chronic pain. This observational study includes a wide range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. The study spans 13 years, covering enrollment, data collection, and study closure, with subjects followed for five years after implantation. Participants will receive one of Abbotts market-released neurostimulation devices, either spinal cord stimulation SCS or dorsal root ganglion stimulation DRG. Individuals scheduled for implantation within 60 days of baseline are eligible. The study is single-arm and open-label, meaning all participants receive the device without randomization or placebo control. During the study, researchers will monitor adverse events, deaths, and device issues at multiple time points from baseline through five years post-implant. Participants will undergo regular safety assessments and provide data on device performance and related outcomes. This comprehensive follow-up will help understand the long-term effects and real-world use of these neurostimulation systems.

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