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

Last updated: August 19, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Spinal cord stimulation (SCS)

Dorsal root ganglion stimulation (DRG)

Clinical Study ID

NCT03876054
ABT-CIP-10279
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject must provide written informed consent prior to any clinical investigationrelated procedure.

  2. Subject is at least 18 years (or the minimum age required by local law to consentfor participation in a clinical investigation) or older at the time of enrollment.

  3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60days of baseline.

  4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion

Exclusion Criteria:

  1. Subject is enrolled, or intends to participate, in a competing clinical study, asdetermined by Abbott.

  2. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-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 chronicpain.

Study Design

Total Participants: 2000
Treatment Group(s): 2
Primary Treatment: Spinal cord stimulation (SCS)
Phase:
Study Start date:
March 13, 2019
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Metro Pain Group

    Clayton, Victoria 3168
    Australia

    Completed

  • Precision Brain, Spine & Pain Centre

    Kew, Victoria 3101
    Australia

    Completed

  • AZ Nikolaas

    Sint-Niklaas, Eflndrs 9100
    Belgium

    Active - Recruiting

  • AZ Delta vzw

    Roeselare, West Flanders 8800
    Belgium

    Active - Recruiting

  • Universitäts Klinikum Tübingen

    Tubingen, Bad-wur 72076
    Germany

    Completed

  • Klinikum Ingolstadt GmbH

    Ingolstadt, Bavaria 85049
    Germany

    Active - Recruiting

  • Klinikum Duisburg GmbH

    Duisburg, N. Rhin 47055
    Germany

    Completed

  • Medizinische Einrichtungen der Universität Düsseldorf

    Dusseldorf, N. Rhin 40225
    Germany

    Active - Recruiting

  • Krankenhaus Neuwerk Maria von den Aposteln

    Monchengladbach, N. Rhin 41066
    Germany

    Active - Recruiting

  • Kliniken der Stadt Köln-Merheim

    Koln, North Rhine-Westphalia 51109
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23538
    Germany

    Completed

  • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

    Gera, Thuringia 07548
    Germany

    Active - Recruiting

  • Krankenhaus Porz am Rhein

    Koln, 51149
    Germany

    Active - Recruiting

  • Azienda Ospedaliera Monaldi

    Napoli, Campani 80131
    Italy

    Active - Recruiting

  • Fondazione Salvatore Maugeri

    Pavia, Lombard 27100
    Italy

    Active - Recruiting

  • Erasmus MC

    Rotterdam, S Holln 3015
    Netherlands

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Completed

  • Hospital Universitario de Salamanca

    Salamanca, Cstleon 37007
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Completed

  • Hôpital du Valais

    Sion, Valais 1951
    Switzerland

    Active - Recruiting

  • Norfolk and Norwich Hospital

    Norwich, England NR4 7UY
    United Kingdom

    Terminated

  • The Walton Centre

    Liverpool, North West England L9 7LJ
    United Kingdom

    Active - Recruiting

  • Southmead Hospital

    Bristol, Sowest BS10 5NB
    United Kingdom

    Terminated

  • Seacroft Hospital

    Leeds, Yorkshire And The Humber LS14 6UH
    United Kingdom

    Active - Recruiting

  • Phoenician Centers for Research & Innovation

    Phoenix, Arizona 85021
    United States

    Completed

  • Pain Institute of Southern Arizona

    Tucson, Arizona 85718
    United States

    Site Not Available

  • California Orthopedics & Spine

    Larkspur, California 94939
    United States

    Completed

  • Restore Orthopedics & Spine Center

    Orange, California 92868
    United States

    Terminated

  • Foothills Pain Management Clinic

    Pomona, California 91767
    United States

    Terminated

  • Pacific Research Institute

    Santa Rosa, California 95403
    United States

    Site Not Available

  • University of Florida Department of Anesthesia

    Gainesville, Florida 32610
    United States

    Completed

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Goodman Campbell Brain and Spine

    Indianapolis, Indiana 46032
    United States

    Site Not Available

  • Nura

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Twin Cities Pain Clinic

    Edina, Minnesota 55439
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Terminated

  • Saint Louis Pain Consultants

    Chesterfield, Missouri 63017
    United States

    Completed

  • Advanced Pain Care

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Nevada Advanced Pain Specialists

    Reno, Nevada 89511
    United States

    Site Not Available

  • Ainsworth Institute of Pain Management

    New York, New York 10022
    United States

    Completed

  • Unity Spine Center

    Rochester, New York 14626
    United States

    Site Not Available

  • The Spine & Pain Institute of New York

    Staten Island, New York 10305
    United States

    Site Not Available

  • Premier Pain Solutions

    Asheville, North Carolina 28803
    United States

    Completed

  • Adena Bone and Joint Center

    Chillicothe, Ohio 45601
    United States

    Site Not Available

  • Premier Pain Treatment Institute

    Loveland, Ohio 45140
    United States

    Site Not Available

  • Pacific Sports & Spine

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Spinal Diagnostics

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Center for Interventional Pain & Spine

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Expert Pain

    Houston, Texas 77079
    United States

    Site Not Available

  • Central Texas Pain Institute

    Killeen, Texas 76542
    United States

    Site Not Available

  • Integrated Pain Associates

    Killeen, Texas 76542
    United States

    Terminated

  • Advanced Pain Care

    Round Rock, Texas 78664
    United States

    Site Not Available

  • The Spine & Nerve Center of St Francis Hospital

    Charleston, West Virginia 25301
    United States

    Site Not Available

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