RecruitingNCT03876054

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

Sponsor

Abbott Medical Devices

Enrollment

2,000 participants

Start Date

Mar 13, 2019

Study Type

OBSERVATIONAL

Conditions

Chronic Pain

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Dorsal root ganglion stimulation (DRG) and a medical device called Spinal cord stimulation (SCS) for people with chronic pain. The study is currently recruiting participants at 55 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpinal cord stimulation (SCS)

Subjects will be implanted with market-released Abbott SCS systems

DEVICEDorsal root ganglion stimulation (DRG)

Subjects will be implanted with market-released Abbott DRG system

Locations(55)

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

Nura

Edina, Minnesota, United States

Twin Cities Pain Clinic

Edina, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Louis Pain Consultants

Chesterfield, Missouri, United States

Advanced Pain Care

Henderson, Nevada, United States

Nevada Advanced Pain Specialists

Reno, Nevada, United States

Ainsworth Institute of Pain Management

New York, New York, United States

Unity Spine Center

Rochester, New York, United States

The Spine & Pain Institute of New York

Staten Island, New York, United States

Premier Pain Solutions

Asheville, North Carolina, United States

Adena Bone and Joint Center

Chillicothe, Ohio, United States

Premier Pain Treatment Institute

Loveland, Ohio, United States

Pacific Sports & Spine

Eugene, Oregon, United States

Spinal Diagnostics

Tualatin, Oregon, United States

Center for Interventional Pain & Spine

Exton, Pennsylvania, United States

Expert Pain

Houston, Texas, United States

Central Texas Pain Institute

Killeen, Texas, United States

Integrated Pain Associates

Killeen, Texas, United States

Advanced Pain Care

Round Rock, Texas, United States

The Spine & Nerve Center of St Francis Hospital

Charleston, West Virginia, United States

Metro Pain Group

Clayton, Victoria, Australia

Precision Brain, Spine & Pain Centre

Kew, Victoria, Australia

AZ Nikolaas

Sint-Niklaas, Eflndrs, Belgium

AZ Delta vzw

Roeselare, West Flanders, Belgium

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, Germany

Klinikum Ingolstadt GmbH

Ingolstadt, Bavaria, Germany

Krankenhaus Porz am Rhein

Cologne, Koln, Germany

Klinikum Duisburg GmbH

Duisburg, N. RHIN, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, N. RHIN, Germany

Krankenhaus Neuwerk Maria von den Aposteln

Mönchengladbach, N. RHIN, Germany

Kliniken der Stadt Köln-Merheim

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

Gera, Thuringia, Germany

Azienda Ospedaliera Monaldi

Naples, 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

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Hôpital du Valais

Sion, Valais, Switzerland

Norfolk and Norwich Hospital

Norwich, England, United Kingdom

The Walton Centre

Liverpool, North West England, United Kingdom

Southmead Hospital

Bristol, Sowest, United Kingdom

Seacroft Hospital

Leeds, Yorkshire and the Humber, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03876054

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