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

Abbott

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: Dorsal root ganglion stimulation (DRG); Device: Spinal cord stimulation (SCS)

Study type: Observational

Funder types: Industry

Identifiers

NCT03876054

ABT-CIP-10279

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

Spinal cord stimulation (SCS)

Description:

Subjects using Abbott SCS systems

Treatment:

Device: Spinal cord stimulation (SCS)

Dorsal root ganglion stimulation (DRG)

Description:

Subjects using Abbott DRG system

Treatment:

Device: Dorsal root ganglion stimulation (DRG)