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

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT03876054
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-12
• Study Start: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2029-06
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of device and procedure related adverse events, deaths, and device deficiencies	5 Years	Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates.; This study has no primary or secondary endpoints, all endpoints are of equal weight.

Trial Locations

Locations (54)

Phoenician Centers for Research & Innovation; 🇺🇸 Phoenix, Arizona, United States

Pain Institute of Southern Arizona; 🇺🇸 Tucson, Arizona, United States

California Orthopedics & Spine; 🇺🇸 Larkspur, California, United States

Restore Orthopedics & Spine Center; 🇺🇸 Orange, California, United States

Foothills Pain Management Clinic; 🇺🇸 Pomona, California, United States

Pacific Research Institute; 🇺🇸 Santa Rosa, California, United States

University of Florida Department of Anesthesia; 🇺🇸 Gainesville, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Goodman Campbell Brain and Spine; 🇺🇸 Indianapolis, Indiana, United States

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