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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Spinal cord stimulation (SCS)
* Device: Dorsal root ganglion stimulation (DRG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal cord stimulation (SCS)<br>Subjects using Abbott SCS systems | Device: Spinal cord stimulation (SCS)<br>* Subjects will be implanted with market-released Abbott SCS systems<br>|
| Dorsal root ganglion stimulation (DRG)<br>Subjects using Abbott DRG system | Device: Dorsal root ganglion stimulation (DRG)<br>* Subjects will be implanted with market-released Abbott DRG system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | Baseline | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | Permanent Implant Procedure | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | 6 months | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and 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. | 9 months | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | 1 Year | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and 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. | 1.5 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | 2 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and 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. | 2.5 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | 3 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and 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. | 3.5 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | 4 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and 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. | 4.5 Years | 
| Rate of device and procedure related adverse events, deaths, and device deficiencies | 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. | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation, dorsal root ganglion stimulation