Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Start Date
3/13/2019
Completion Date
12/1/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Spinal cord stimulation (SCS)
Dorsal root ganglion stimulation (DRG)
Conditions
Locations
Phoenician Centers for Research & Innovation
Phoenix, Arizona 85021
United States
Pain Institute of Southern Arizona
Tucson, Arizona 85718
United States
California Orthopedics & Spine
Larkspur, California 94939
United States
Restore Orthopedics & Spine Center
Orange, California 92868
United States
Foothills Pain Management Clinic
Pomona, California 91767
United States
Pacific Research Institute
Santa Rosa, California 95403
United States
University of Florida Department of Anesthesia
Gainesville, Florida 32610
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Chicago
Chicago, Illinois 60637
United States
Goodman Campbell Brain and Spine
Indianapolis, Indiana 46032
United States
Nura
Edina, Minnesota 55435
United States
Twin Cities Pain Clinic
Edina, Minnesota 55439
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Saint Louis Pain Consultants
Chesterfield, Missouri 63017
United States
Advanced Pain Care
Henderson, Nevada 89052
United States
Nevada Advanced Pain Specialists
Reno, Nevada 89511
United States
Ainsworth Institute of Pain Management
New York, New York 10022
United States
Unity Spine Center
Rochester, New York 14626
United States
The Spine & Pain Institute of New York
Staten Island, New York 10305
United States
Premier Pain Solutions
Asheville, North Carolina 28803
United States
Adena Bone and Joint Center
Chillicothe, Ohio 45601
United States
Premier Pain Treatment Institute
Loveland, Ohio 45140
United States
Pacific Sports & Spine
Eugene, Oregon 97401
United States
Spinal Diagnostics
Tualatin, Oregon 97062
United States
Center for Interventional Pain & Spine
Exton, Pennsylvania 19341
United States
Expert Pain
Houston, Texas 77079
United States
Central Texas Pain Institute
Killeen, Texas 76542
United States
Integrated Pain Associates
Killeen, Texas 76542
United States
Advanced Pain Care
Round Rock, Texas 78664
United States
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia 25301
United States
Metro Pain Group
Clayton, Victoria 3168
Australia
Precision Brain, Spine & Pain Centre
Kew, Victoria 3101
Australia
AZ Nikolaas
Sint-Niklaas, Eflndrs 9100
Belgium
AZ Delta vzw
Roeselare, West Flanders 8800
Belgium
Universitäts Klinikum Tübingen
Tübingen, Bad-wur 72076
Germany
Klinikum Ingolstadt GmbH
Ingolstadt, Bavaria 85049
Germany
Krankenhaus Porz am Rhein
Cologne, Koln 51149
Germany
Klinikum Duisburg GmbH
Duisburg, N. RHIN 47055
Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, N. RHIN 40225
Germany
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach, N. RHIN 41066
Germany
Kliniken der Stadt Köln-Merheim
Cologne, North Rhine-Westphalia 51109
Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein 23538
Germany
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
Gera, Thuringia 07548
Germany
Azienda Ospedaliera Monaldi
Naples, Campani 80131
Italy
Fondazione Salvatore Maugeri
Pavia, Lombard 27100
Italy
Erasmus MC
Rotterdam, S Holln 3015
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht 3435 CM
Netherlands
Hospital Universitario de Salamanca
Salamanca, Cstleon 37007
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222
Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia 46026
Spain
Hôpital du Valais
Sion, Valais 1951
Switzerland
Norfolk and Norwich Hospital
Norwich, England NR4 7UY
United Kingdom
The Walton Centre
Liverpool, North West England L9 7LJ
United Kingdom
Southmead Hospital
Bristol, Sowest BS10 5NB
United Kingdom
Seacroft Hospital
Leeds, Yorkshire and the Humber LS14 6UH
United Kingdom