Spinal cord stimulation (SCS): Subjects will be implanted with market-released Abbott SCS systems
Dorsal root ganglion stimulation (DRG): Subjects will be implanted with market-released Abbott DRG system
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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.
Exclusion Criteria:
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.
Primary outcome measure(s)
Rate of device and procedure related adverse events, deaths, and device deficiencies — Baseline 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — Permanent Implant Procedure 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 6 months 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 9 months 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 1 Year 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 1.5 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 2 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 2.5 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 3 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 3.5 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 4 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 4.5 Years 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.
Rate of device and procedure related adverse events, deaths, and device deficiencies — 5 Years 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.
Trial sites (55)
Facility
City
Region
Status
Phoenician Centers for Research & Innovation
Phoenix
Arizona
Terminated
Pain Institute of Southern Arizona
Tucson
Arizona
Terminated
California Orthopedics & Spine
Larkspur
California
Terminated
Restore Orthopedics & Spine Center
Orange
California
Terminated
Foothills Pain Management Clinic
Pomona
California
Terminated
Pacific Research Institute
Santa Rosa
California
Terminated
University of Florida Department of Anesthesia
Gainesville
Florida
Terminated
Rush University Medical Center
Chicago
Illinois
Active Not Recruiting
University of Chicago
Chicago
Illinois
Active Not Recruiting
Goodman Campbell Brain and Spine
Indianapolis
Indiana
Active Not Recruiting
Nura
Edina
Minnesota
Active Not Recruiting
Twin Cities Pain Clinic
Edina
Minnesota
Terminated
Mayo Clinic
Rochester
Minnesota
Terminated
Saint Louis Pain Consultants
Chesterfield
Missouri
Terminated
Advanced Pain Care
Henderson
Nevada
Terminated
Nevada Advanced Pain Specialists
Reno
Nevada
Terminated
Ainsworth Institute of Pain Management
New York
New York
Terminated
Unity Spine Center
Rochester
New York
Active Not Recruiting
The Spine & Pain Institute of New York
Staten Island
New York
Active Not Recruiting
Premier Pain Solutions
Asheville
North Carolina
Terminated
Adena Bone and Joint Center
Chillicothe
Ohio
Withdrawn
Premier Pain Treatment Institute
Loveland
Ohio
Withdrawn
Pacific Sports & Spine
Eugene
Oregon
Active Not Recruiting
Spinal Diagnostics
Tualatin
Oregon
Terminated
Center for Interventional Pain & Spine
Exton
Pennsylvania
Active Not Recruiting
Expert Pain
Houston
Texas
Active Not Recruiting
Central Texas Pain Institute
Killeen
Texas
Terminated
Integrated Pain Associates
Killeen
Texas
Terminated
Advanced Pain Care
Round Rock
Texas
Terminated
The Spine & Nerve Center of St Francis Hospital
Charleston
West Virginia
Active Not Recruiting
Metro Pain Group
Clayton
Victoria
Terminated
Precision Brain, Spine & Pain Centre
Kew
Victoria
Terminated
AZ Nikolaas
Sint-Niklaas
Eflndrs
Terminated
AZ Delta vzw
Roeselare
West Flanders
Terminated
Universitäts Klinikum Tübingen
Tübingen
Bad-wur
Terminated
Klinikum Ingolstadt GmbH
Ingolstadt
Bavaria
Active Not Recruiting
Krankenhaus Porz am Rhein
Cologne
Koln
Recruiting
Klinikum Duisburg GmbH
Duisburg
N. RHIN
Terminated
Universitaetsklinikum Duesseldorf
Düsseldorf
N. RHIN
Active Not Recruiting
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach
N. RHIN
Terminated
+ 15 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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