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

Abbott Medical Devices81 个研究点分布在 7 个国家目标入组 2,000 人开始时间: 2019年3月13日最近更新: 2026年1月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Abbott Medical Devices
入组人数: 2,000
试验地点: 81
主要终点: Rate of device and procedure related adverse events, deaths, and device deficiencies

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.
•Subject has an existing implanted neuromodulation device to address their chronic pain.

研究组 & 干预措施

Spinal cord stimulation (SCS)

Subjects using Abbott SCS systems

干预措施: Spinal cord stimulation (SCS) (Device)

Dorsal root ganglion stimulation (DRG)

Subjects using Abbott DRG system

干预措施: Dorsal root ganglion stimulation (DRG) (Device)