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Clinical Trials in the Netherlands / NCT03876054
Recruiting Observational

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

NCT03876054 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2019-03-13
Last updated
2026-01-07

Condition(s) studied

Chronic Pain

Investigational drug(s) / intervention(s)

Spinal cord stimulation (SCS)Dorsal root ganglion stimulation (DRG)

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)

FacilityCityRegionStatus
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.

More Abbott Medical Devices trials in the Netherlands

Post-Market Clinical Follow Up Study With Navitor Valve Recruiting
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation Active, not recruiting
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study Recruiting
SyncAV Post-Market Trial Active, not recruiting
PARADIGM: Amplatzer Valvular Plug for PVL Closure Active, not recruiting

Other trials for the same condition

Pain Predict Genetics Active, not recruiting
Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs Active, not recruiting
Patient Retrospective Outcomes (PRO) Recruiting
Natural Course of Pain Following Surgery Through an Abdominal Incision Active, not recruiting
Official registry record

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.

View NCT03876054 on ClinicalTrials.gov ↗ ← All trials in the Netherlands