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

NCT03876054 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10279
• Study Type: observational
• Target: 2,000
• Locations: 9 countries
• Sites: 55

Brief 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.

Conditions

Chronic Pain

Keywords

spinal cord stimulation; dorsal root ganglion stimulation

Outcome Measures

Primary Outcomes (13)

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  Baseline

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  Permanent Implant Procedure

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  6 months

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  9 months

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  1 Year

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  1.5 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  2 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  2.5 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  3 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  3.5 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  4 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be assessed via Telephone Calls and will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  4.5 Years

• Rate of device and procedure related adverse events, deaths, and device deficiencies

  Serious adverse device effects (SADEs), adverse device effects (ADEs), deaths, and device deficiencies will be summarized using counts, percentages or Kaplan-Meier survival estimates. This study has no primary or secondary endpoints, all endpoints are of equal weight.

  5 Years

Other Outcomes (58)

• Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

  6 months

• Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

  1 Year

• Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29

  2 Years

Study Arms (2)

Spinal cord stimulation (SCS)

Subjects using Abbott SCS systems

Device: Spinal cord stimulation (SCS)

Dorsal root ganglion stimulation (DRG)

Subjects using Abbott DRG system

Device: Dorsal root ganglion stimulation (DRG)

Interventions

Spinal cord stimulation (SCS) DEVICE

Subjects will be implanted with market-released Abbott SCS systems

Spinal cord stimulation (SCS)

Dorsal root ganglion stimulation (DRG) DEVICE

Subjects will be implanted with market-released Abbott DRG system

Dorsal root ganglion stimulation (DRG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

You may qualify if:

• Subject must provide written informed consent prior to any clinical investigation related procedure.
• 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.
• Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
• Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

You may not qualify if:

• Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
• 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.
• Subject has or is scheduled to receive an intrathecal pump.
• Subject is part of a vulnerable population.
• Subject has an existing implanted neuromodulation device to address their chronic pain.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (55)

Phoenician Centers for Research & Innovation

Phoenix, Arizona, 85021, United States

TERMINATED

Pain Institute of Southern Arizona

Tucson, Arizona, 85718, United States

TERMINATED

California Orthopedics & Spine

Larkspur, California, 94939, United States

TERMINATED

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

TERMINATED

University of Florida Department of Anesthesia

Gainesville, Florida, 32610, United States

TERMINATED

Rush University Medical Center

Chicago, Illinois, 60612, United States

ACTIVE NOT RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

ACTIVE NOT RECRUITING

Goodman Campbell Brain and Spine

Indianapolis, Indiana, 46032, United States

ACTIVE NOT RECRUITING

Nura

Edina, Minnesota, 55435, United States

ACTIVE NOT RECRUITING

Twin Cities Pain Clinic

Edina, Minnesota, 55439, United States

TERMINATED

Mayo Clinic

Rochester, Minnesota, 55905, United States

TERMINATED

Saint Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

TERMINATED

Advanced Pain Care

Henderson, Nevada, 89052, United States

TERMINATED

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

TERMINATED

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

TERMINATED

Unity Spine Center

Rochester, New York, 14626, United States

ACTIVE NOT RECRUITING

The Spine & Pain Institute of New York

Staten Island, New York, 10305, United States

ACTIVE NOT RECRUITING

Premier Pain Solutions

Asheville, North Carolina, 28803, United States

TERMINATED

Adena Bone and Joint Center

Chillicothe, Ohio, 45601, United States

WITHDRAWN

Premier Pain Treatment Institute

Loveland, Ohio, 45140, United States

WITHDRAWN

Pacific Sports & Spine

Eugene, Oregon, 97401, United States

ACTIVE NOT RECRUITING

Spinal Diagnostics

Tualatin, Oregon, 97062, United States

TERMINATED

Center for Interventional Pain & Spine

Exton, Pennsylvania, 19341, United States

ACTIVE NOT RECRUITING

Expert Pain

Houston, Texas, 77079, United States

ACTIVE NOT RECRUITING

Central Texas Pain Institute

Killeen, Texas, 76542, United States

TERMINATED

Integrated Pain Associates

Killeen, Texas, 76542, United States

TERMINATED

Advanced Pain Care

Round Rock, Texas, 78664, United States

TERMINATED

The Spine & Nerve Center of St Francis Hospital

Charleston, West Virginia, 25301, United States

ACTIVE NOT RECRUITING

Metro Pain Group

Clayton, Victoria, 3168, Australia

TERMINATED

Precision Brain, Spine & Pain Centre

Kew, Victoria, 3101, Australia

TERMINATED

AZ Nikolaas

Sint-Niklaas, Eflndrs, 9100, Belgium

TERMINATED

AZ Delta vzw

Roeselare, West Flanders, 8800, Belgium

TERMINATED

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, 72076, Germany

TERMINATED

Klinikum Ingolstadt GmbH

Ingolstadt, Bavaria, 85049, Germany

ACTIVE NOT RECRUITING

Krankenhaus Porz am Rhein

Cologne, Koln, 51149, Germany

RECRUITING

Klinikum Duisburg GmbH

Duisburg, N. RHIN, 47055, Germany

TERMINATED

Universitaetsklinikum Duesseldorf

Düsseldorf, N. RHIN, 40225, Germany

ACTIVE NOT RECRUITING

Krankenhaus Neuwerk Maria von den Aposteln

Mönchengladbach, N. RHIN, 41066, Germany

TERMINATED

Kliniken der Stadt Köln-Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

TERMINATED

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

TERMINATED

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

Gera, Thuringia, 07548, Germany

TERMINATED

Azienda Ospedaliera Monaldi

Naples, Campani, 80131, Italy

ACTIVE NOT RECRUITING

Fondazione Salvatore Maugeri

Pavia, Lombard, 27100, Italy

ACTIVE NOT RECRUITING

Erasmus MC

Rotterdam, S Holln, 3015, Netherlands

ACTIVE NOT RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

TERMINATED

Hospital Universitario de Salamanca

Salamanca, Cstleon, 37007, Spain

TERMINATED

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

TERMINATED

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

TERMINATED

Hôpital du Valais

Sion, Valais, 1951, Switzerland

ACTIVE NOT RECRUITING

Norfolk and Norwich Hospital

Norwich, England, NR4 7UY, United Kingdom

TERMINATED

The Walton Centre

Liverpool, North West England, L9 7LJ, United Kingdom

TERMINATED

Southmead Hospital

Bristol, Sowest, BS10 5NB, United Kingdom

TERMINATED

Seacroft Hospital

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

TERMINATED

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Devyani Nanduri

  Abbott Medical Devices Neuromodulation

  STUDY DIRECTOR

Central Study Contacts

Bram Blomme

CONTACT

+32 474 74 83 10; bram.blomme@abbott.com

Sonar Pradhan

CONTACT

+1 818-282-6456; sonar.pradhan@abbott.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: March 13, 2019
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); ES (3); AU (2); BE (2); DE (9); IT (2); CH (1); NL (2); US (30)