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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Pain
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenician Centers for Research & Innovation, Phoenix, Arizona, United States, 85021

Tucson

Pain Institute of Southern Arizona, Tucson, Arizona, United States, 85718

Larkspur

California Orthopedics & Spine, Larkspur, California, United States, 94939

Orange

Restore Orthopedics & Spine Center, Orange, California, United States, 92868

Pomona

Foothills Pain Management Clinic, Pomona, California, United States, 91767

Santa Rosa

Pacific Research Institute, Santa Rosa, California, United States, 95403

Gainesville

University of Florida Department of Anesthesia, Gainesville, Florida, United States, 32610

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Indianapolis

Goodman Campbell Brain and Spine, Indianapolis, Indiana, United States, 46032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Devyani Nanduri, STUDY_DIRECTOR, Abbott Medical Devices Neuromodulation

Study Record Dates

2029-12