NCT03876054

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Spinal cord stimulation (SCS)	Subjects will be implanted with market-released Abbott SCS systems
DEVICE	Dorsal root ganglion stimulation (DRG)	Subjects will be implanted with market-released Abbott DRG system

Timeline

• Start date: 2019-03-13
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2019-03-15
• Last updated: 2026-01-07

Locations

55 sites across 9 countries: United States, Australia, Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study