Actively Recruiting

Age: 18Years +
All Genders
NCT03876054

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

Led by Abbott Medical Devices · Updated on 2026-01-07

2000

Participants Needed

55

Research Sites

559 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject must provide written informed consent prior to any clinical investigation related procedure.
  • Subject is at least 18 years 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 pain numeric rating scale (NRS) score of 6 or higher without stimulation.
Not Eligible

You will not qualify if you...

  • Subject is enrolled, or intends to participate, in a competing clinical study.
  • Subject has other anatomic, medical, social, or psychological conditions limiting participation or follow-up compliance.
  • Subject has or is scheduled to receive an intrathecal pump.
  • Subject is part of a vulnerable population.
  • Subject has an existing implanted neuromodulation device for chronic pain.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 55 locations

1

Phoenician Centers for Research & Innovation

Phoenix, Arizona, United States, 85021

Terminated

2

Pain Institute of Southern Arizona

Tucson, Arizona, United States, 85718

Terminated

3

California Orthopedics & Spine

Larkspur, California, United States, 94939

Terminated

4

Restore Orthopedics & Spine Center

Orange, California, United States, 92868

Terminated

5

Foothills Pain Management Clinic

Pomona, California, United States, 91767

Terminated

6

Pacific Research Institute

Santa Rosa, California, United States, 95403

Terminated

7

University of Florida Department of Anesthesia

Gainesville, Florida, United States, 32610

Terminated

8

Rush University Medical Center

Chicago, Illinois, United States, 60612

Active, Not Recruiting

9

University of Chicago

Chicago, Illinois, United States, 60637

Active, Not Recruiting

10

Goodman Campbell Brain and Spine

Indianapolis, Indiana, United States, 46032

Active, Not Recruiting

11

Nura

Edina, Minnesota, United States, 55435

Active, Not Recruiting

12

Twin Cities Pain Clinic

Edina, Minnesota, United States, 55439

Terminated

13

Mayo Clinic

Rochester, Minnesota, United States, 55905

Terminated

14

Saint Louis Pain Consultants

Chesterfield, Missouri, United States, 63017

Terminated

15

Advanced Pain Care

Henderson, Nevada, United States, 89052

Terminated

16

Nevada Advanced Pain Specialists

Reno, Nevada, United States, 89511

Terminated

17

Ainsworth Institute of Pain Management

New York, New York, United States, 10022

Terminated

18

Unity Spine Center

Rochester, New York, United States, 14626

Active, Not Recruiting

19

The Spine & Pain Institute of New York

Staten Island, New York, United States, 10305

Active, Not Recruiting

20

Premier Pain Solutions

Asheville, North Carolina, United States, 28803

Terminated

21

Adena Bone and Joint Center

Chillicothe, Ohio, United States, 45601

Withdrawn

22

Premier Pain Treatment Institute

Loveland, Ohio, United States, 45140

Withdrawn

23

Pacific Sports & Spine

Eugene, Oregon, United States, 97401

Active, Not Recruiting

24

Spinal Diagnostics

Tualatin, Oregon, United States, 97062

Terminated

25

Center for Interventional Pain & Spine

Exton, Pennsylvania, United States, 19341

Active, Not Recruiting

26

Expert Pain

Houston, Texas, United States, 77079

Active, Not Recruiting

27

Central Texas Pain Institute

Killeen, Texas, United States, 76542

Terminated

28

Integrated Pain Associates

Killeen, Texas, United States, 76542

Terminated

29

Advanced Pain Care

Round Rock, Texas, United States, 78664

Terminated

30

The Spine & Nerve Center of St Francis Hospital

Charleston, West Virginia, United States, 25301

Active, Not Recruiting

31

Metro Pain Group

Clayton, Victoria, Australia, 3168

Terminated

32

Precision Brain, Spine & Pain Centre

Kew, Victoria, Australia, 3101

Terminated

33

AZ Nikolaas

Sint-Niklaas, Eflndrs, Belgium, 9100

Terminated

34

AZ Delta vzw

Roeselare, West Flanders, Belgium, 8800

Terminated

35

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, Germany, 72076

Terminated

36

Klinikum Ingolstadt GmbH

Ingolstadt, Bavaria, Germany, 85049

Active, Not Recruiting

37

Krankenhaus Porz am Rhein

Cologne, Koln, Germany, 51149

Actively Recruiting

38

Klinikum Duisburg GmbH

Duisburg, N. RHIN, Germany, 47055

Terminated

39

Universitaetsklinikum Duesseldorf

Düsseldorf, N. RHIN, Germany, 40225

Active, Not Recruiting

40

Krankenhaus Neuwerk Maria von den Aposteln

Mönchengladbach, N. RHIN, Germany, 41066

Terminated

41

Kliniken der Stadt Köln-Merheim

Cologne, North Rhine-Westphalia, Germany, 51109

Terminated

42

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany, 23538

Terminated

43

Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie

Gera, Thuringia, Germany, 07548

Terminated

44

Azienda Ospedaliera Monaldi

Naples, Campani, Italy, 80131

Active, Not Recruiting

45

Fondazione Salvatore Maugeri

Pavia, Lombard, Italy, 27100

Active, Not Recruiting

46

Erasmus MC

Rotterdam, S Holln, Netherlands, 3015

Active, Not Recruiting

47

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands, 3435 CM

Terminated

48

Hospital Universitario de Salamanca

Salamanca, Cstleon, Spain, 37007

Terminated

49

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain, 28222

Terminated

50

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain, 46026

Terminated

51

Hôpital du Valais

Sion, Valais, Switzerland, 1951

Active, Not Recruiting

52

Norfolk and Norwich Hospital

Norwich, England, United Kingdom, NR4 7UY

Terminated

53

The Walton Centre

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

Terminated

54

Southmead Hospital

Bristol, Sowest, United Kingdom, BS10 5NB

Terminated

55

Seacroft Hospital

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

Terminated

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Research Team

B

Bram Blomme

CONTACT

S

Sonar Pradhan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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