Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
- Conditions
- Chronic Pain
- Interventions
- Device: Spinal cord stimulation (SCS)Device: Dorsal root ganglion stimulation (DRG)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spinal cord stimulation (SCS) Spinal cord stimulation (SCS) Subjects using Abbott SCS systems Dorsal root ganglion stimulation (DRG) Dorsal root ganglion stimulation (DRG) Subjects using Abbott DRG system
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
Saint Louis Pain Consultants
🇺🇸Chesterfield, Missouri, United States
The Spine & Pain Institute of New York
🇺🇸Staten Island, New York, United States
The Spine & Nerve Center of St Francis Hospital
🇺🇸Charleston, West Virginia, United States
Advanced Pain Care
🇺🇸Round Rock, Texas, United States
Kliniken der Stadt Köln-Merheim
🇩🇪Koln, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Phoenician Centers for Research & Innovation
🇺🇸Phoenix, Arizona, United States
Pain Institute of Southern Arizona
🇺🇸Tucson, Arizona, United States
Restore Orthopedics & Spine Center
🇺🇸Orange, California, United States
California Orthopedics & Spine
🇺🇸Larkspur, California, United States
University of Florida Department of Anesthesia
🇺🇸Gainesville, Florida, United States
Foothills Pain Management Clinic
🇺🇸Pomona, California, 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
Nura
🇺🇸Edina, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Nevada Advanced Pain Specialists
🇺🇸Reno, Nevada, United States
Ainsworth Institute of Pain Management
🇺🇸New York, New York, United States
Premier Pain Solutions
🇺🇸Asheville, North Carolina, United States
Center for Interventional Pain & Spine
🇺🇸Exton, Pennsylvania, United States
Adena Bone and Joint Center
🇺🇸Chillicothe, Ohio, United States
Premier Pain Treatment Institute
🇺🇸Loveland, Ohio, United States
Metro Pain Group
🇦🇺Clayton, Victoria, Australia
Expert Pain
🇺🇸Houston, Texas, United States
Central Texas Pain Institute
🇺🇸Killeen, Texas, United States
Integrated Pain Associates
🇺🇸Killeen, Texas, United States
Precision Brain, Spine & Pain Centre
🇦🇺Kew, Victoria, Australia
AZ Nikolaas
🇧🇪Sint-Niklaas, Eflndrs, Belgium
Universitäts Klinikum Tübingen
🇩🇪Tubingen, Bad-wur, Germany
AZ Delta vzw
🇧🇪Roeselare, West Flanders, Belgium
Klinikum Duisburg GmbH
🇩🇪Duisburg, N. Rhin, Germany
Medizinische Einrichtungen der Universität Düsseldorf
🇩🇪Dusseldorf, N. Rhin, Germany
Krankenhaus Porz am Rhein
🇩🇪Koln, Germany
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
🇩🇪Gera, Thuringia, Germany
Azienda Ospedaliera Monaldi
🇮🇹Napoli, Campani, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Lombard, Italy
Erasmus MC
🇳🇱Rotterdam, S Holln, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Utrecht, Netherlands
Hospital Universitario de Salamanca
🇪🇸Salamanca, Cstleon, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
The Walton Centre
🇬🇧Liverpool, North West England, United Kingdom
Southmead Hospital
🇬🇧Bristol, Sowest, United Kingdom
Seacroft Hospital
🇬🇧Leeds, Yorkshire And The Humber, United Kingdom
Krankenhaus Neuwerk Maria von den Aposteln
🇩🇪Monchengladbach, N. Rhin, Germany
Unity Spine Center
🇺🇸Rochester, New York, United States
Pacific Research Institute
🇺🇸Santa Rosa, California, United States
Pacific Sports & Spine
🇺🇸Eugene, Oregon, United States
Spinal Diagnostics
🇺🇸Tualatin, Oregon, United States
Twin Cities Pain Clinic
🇺🇸Edina, Minnesota, United States
Klinikum Ingolstadt GmbH
🇩🇪Ingolstadt, Bavaria, Germany
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hôpital du Valais
🇨🇭Sion, Valais, Switzerland
Norfolk and Norwich Hospital
🇬🇧Norwich, England, United Kingdom