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NCT03876054Recruiting

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

Abbott Medical Devices

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

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.

Interventions

DEVICE

Spinal cord stimulation (SCS)

DEVICE

Dorsal root ganglion stimulation (DRG)

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Conditions

Chronic Pain

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