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

Last updated: January 5, 2026
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Dorsal root ganglion stimulation (DRG)

Spinal cord stimulation (SCS)

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: Dorsal root ganglion stimulation (DRG)
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

    Site Not Available

  • Precision Brain, Spine & Pain Centre

    Kew, Victoria 3101
    Australia

    Site Not Available

  • Metro Pain Group

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Terminated

  • Precision Brain, Spine & Pain Centre

    Kew 2161540, Victoria 2145234 3101
    Australia

    Terminated

  • AZ Nikolaas

    Sint-Niklaas, Eflndrs 9100
    Belgium

    Site Not Available

  • AZ Nikolaas

    Sint-Niklaas 2786578, Eflndrs 9100
    Belgium

    Terminated

  • AZ Delta vzw

    Roeselare, West Flanders 8800
    Belgium

    Site Not Available

  • AZ Delta vzw

    Roeselare 2787889, West Flanders 8800
    Belgium

    Terminated

  • Universitäts Klinikum Tübingen

    Tubingen, Bad-wur 72076
    Germany

    Site Not Available

  • Universitäts Klinikum Tübingen

    Tübingen 2820860, Bad-wur 72076
    Germany

    Terminated

  • Klinikum Ingolstadt GmbH

    Ingolstadt, Bavaria 85049
    Germany

    Site Not Available

  • Klinikum Ingolstadt GmbH

    Ingolstadt 2895992, Bavaria 2951839 85049
    Germany

    Site Not Available

  • Krankenhaus Porz am Rhein

    Cologne 2886242, Koln 51149
    Germany

    Active - Recruiting

  • Klinikum Duisburg GmbH

    Duisburg 2934691, N. RHIN 47055
    Germany

    Terminated

  • Universitaetsklinikum Duesseldorf

    Düsseldorf 2934246, N. RHIN 40225
    Germany

    Site Not Available

  • Krankenhaus Neuwerk Maria von den Aposteln

    Mönchengladbach 2869894, N. RHIN 41066
    Germany

    Terminated

  • Klinikum Duisburg GmbH

    Duisburg, N. Rhin 47055
    Germany

    Site Not Available

  • Medizinische Einrichtungen der Universität Düsseldorf

    Dusseldorf, N. Rhin 40225
    Germany

    Active - Recruiting

  • Universitaetsklinikum Duesseldorf

    Dusseldorf, N. Rhin 40225
    Germany

    Site Not Available

  • Krankenhaus Neuwerk Maria von den Aposteln

    Monchengladbach, N. Rhin 41066
    Germany

    Site Not Available

  • Kliniken der Stadt Köln-Merheim

    Koln, North Rhine-Westphalia 51109
    Germany

    Site Not Available

  • Kliniken der Stadt Köln-Merheim

    Cologne 2886242, North Rhine-Westphalia 2861876 51109
    Germany

    Terminated

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lübeck 2875601, Schleswig-Holstein 2838632 23538
    Germany

    Terminated

  • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

    Gera, Thuringia 07548
    Germany

    Site Not Available

  • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

    Gera 2921232, Thuringia 2822542 07548
    Germany

    Terminated

  • Krankenhaus Porz am Rhein

    Koln, 51149
    Germany

    Active - Recruiting

  • Azienda Ospedaliera Monaldi

    Napoli, Campani 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Monaldi

    Napoli 9031661, Campani 80131
    Italy

    Site Not Available

  • Fondazione Salvatore Maugeri

    Pavia, Lombard 27100
    Italy

    Site Not Available

  • Fondazione Salvatore Maugeri

    Pavia 3171366, Lombard 27100
    Italy

    Site Not Available

  • Erasmus MC

    Rotterdam, S Holln 3015
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam 2747891, S Holln 3015
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein 2750325, Utrecht 2745909 3435 CM
    Netherlands

    Terminated

  • Hospital Universitario de Salamanca

    Salamanca, Cstleon 37007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca 3111108, Cstleon 37007
    Spain

    Terminated

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Terminated

  • Hospital Universitari i Politècnic La Fe

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Terminated

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hôpital du Valais

    Sion, Valais 1951
    Switzerland

    Site Not Available

  • Hôpital du Valais

    Sion 2658576, Valais 2658205 1951
    Switzerland

    Site Not Available

  • Norfolk and Norwich Hospital

    Norwich, England NR4 7UY
    United Kingdom

    Site Not Available

  • Norfolk and Norwich Hospital

    Norwich 2641181, England 6269131 NR4 7UY
    United Kingdom

    Terminated

  • The Walton Centre

    Liverpool, North West England L9 7LJ
    United Kingdom

    Site Not Available

  • The Walton Centre

    Liverpool 2644210, North West England L9 7LJ
    United Kingdom

    Terminated

  • Southmead Hospital

    Bristol, Sowest BS10 5NB
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol 2654675, Sowest BS10 5NB
    United Kingdom

    Terminated

  • Seacroft Hospital

    Leeds, Yorkshire And The Humber LS14 6UH
    United Kingdom

    Site Not Available

  • Seacroft Hospital

    Leeds 2644688, Yorkshire and the Humber LS14 6UH
    United Kingdom

    Terminated

  • Phoenician Centers for Research & Innovation

    Phoenix, Arizona 85021
    United States

    Site Not Available

  • Pain Institute of Southern Arizona

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Phoenician Centers for Research & Innovation

    Phoenix 5308655, Arizona 5551752 85021
    United States

    Terminated

  • Pain Institute of Southern Arizona

    Tucson 5318313, Arizona 5551752 85718
    United States

    Terminated

  • California Orthopedics & Spine

    Larkspur, California 94939
    United States

    Site Not Available

  • Restore Orthopedics & Spine Center

    Orange, California 92868
    United States

    Site Not Available

  • Foothills Pain Management Clinic

    Pomona, California 91767
    United States

    Site Not Available

  • Pacific Research Institute

    Santa Rosa, California 95403
    United States

    Site Not Available

  • California Orthopedics & Spine

    Larkspur 5365113, California 5332921 94939
    United States

    Terminated

  • Restore Orthopedics & Spine Center

    Orange 5379513, California 5332921 92868
    United States

    Terminated

  • Foothills Pain Management Clinic

    Pomona 5384170, California 5332921 91767
    United States

    Terminated

  • Pacific Research Institute

    Santa Rosa 5393287, California 5332921 95403
    United States

    Terminated

  • University of Florida Department of Anesthesia

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Florida Department of Anesthesia

    Gainesville 4156404, Florida 4155751 32610
    United States

    Terminated

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Goodman Campbell Brain and Spine

    Indianapolis, Indiana 46032
    United States

    Site Not Available

  • Goodman Campbell Brain and Spine

    Indianapolis 4259418, Indiana 4921868 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

    Site Not Available

  • Nura

    Edina 5025264, Minnesota 5037779 55435
    United States

    Site Not Available

  • Twin Cities Pain Clinic

    Edina 5025264, Minnesota 5037779 55439
    United States

    Terminated

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Terminated

  • Saint Louis Pain Consultants

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Saint Louis Pain Consultants

    Chesterfield 4381072, Missouri 4398678 63017
    United States

    Terminated

  • Advanced Pain Care

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Nevada Advanced Pain Specialists

    Reno, Nevada 89511
    United States

    Site Not Available

  • Advanced Pain Care

    Henderson 5505411, Nevada 5509151 89052
    United States

    Terminated

  • Nevada Advanced Pain Specialists

    Reno 5511077, Nevada 5509151 89511
    United States

    Terminated

  • Ainsworth Institute of Pain Management

    New York, New York 10022
    United States

    Site Not Available

  • 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

  • Ainsworth Institute of Pain Management

    New York 5128581, New York 5128638 10022
    United States

    Terminated

  • Unity Spine Center

    Rochester 5134086, New York 5128638 14626
    United States

    Site Not Available

  • The Spine & Pain Institute of New York

    Staten Island 5139568, New York 5128638 10305
    United States

    Site Not Available

  • Premier Pain Solutions

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Premier Pain Solutions

    Asheville 4453066, North Carolina 4482348 28803
    United States

    Terminated

  • 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

  • Adena Bone and Joint Center

    Chillicothe 4828890, Ohio 5165418 45601
    United States

    Site Not Available

  • Premier Pain Treatment Institute

    Loveland 4517140, Ohio 5165418 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

  • Pacific Sports & Spine

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • Spinal Diagnostics

    Tualatin 5757506, Oregon 5744337 97062
    United States

    Terminated

  • Center for Interventional Pain & Spine

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Center for Interventional Pain & Spine

    Exton 5189022, Pennsylvania 6254927 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

    Site Not Available

  • Advanced Pain Care

    Round Rock, Texas 78664
    United States

    Site Not Available

  • Expert Pain

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Central Texas Pain Institute

    Killeen 4703223, Texas 4736286 76542
    United States

    Terminated

  • Integrated Pain Associates

    Killeen 4703223, Texas 4736286 76542
    United States

    Terminated

  • Advanced Pain Care

    Round Rock 4724129, Texas 4736286 78664
    United States

    Terminated

  • The Spine & Nerve Center of St Francis Hospital

    Charleston, West Virginia 25301
    United States

    Site Not Available

  • The Spine & Nerve Center of St Francis Hospital

    Charleston 4801859, West Virginia 4826850 25301
    United States

    Site Not Available

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