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

NCT ID: NCT03876054
Registry status: Recruiting
Study type: Observational
Sponsor: Abbott Medical Devices
Conditions: Chronic Pain

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 2000 participants (Estimated).

What is being studied

Device: Dorsal root ganglion stimulation (DRG)
Intervention: Electric Stimulation Therapy
Intervention: Physical Therapy Modalities
Intervention: Rehabilitation
Intervention: Spinal Cord Stimulation
Device: Spinal cord stimulation (SCS)
Intervention: Therapeutics

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: Not specified in the registry data

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

55 study locations are listed.

Recruiting site status is explicitly provided for 55 locations; 1 is listed as Recruiting.

Countries: Australia, Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Victoria, Australia: 2
Eflndrs, Belgium: 1
West Flanders, Belgium: 1
Bad-wur, Germany: 1
Bavaria, Germany: 1
Koln, Germany: 1
N. RHIN, Germany: 3
North Rhine-Westphalia, Germany: 1
Schleswig-Holstein, Germany: 1
Thuringia, Germany: 1
Campani, Italy: 1
Lombard, Italy: 1
S Holln, Netherlands: 1
Utrecht, Netherlands: 1
Cstleon, Spain: 1
Madrid, Spain: 1
Valencia, Spain: 1
Valais, Switzerland: 1
England, United Kingdom: 1
North West England, United Kingdom: 1
Sowest, United Kingdom: 1
Yorkshire and the Humber, United Kingdom: 1
Arizona, United States: 2
California, United States: 4
Florida, United States: 1
Illinois, United States: 2
Indiana, United States: 1
Minnesota, United States: 3
Missouri, United States: 1
Nevada, United States: 2

Sample of listed locations

Krankenhaus Porz am Rhein — Cologne, Koln, 51149, Germany — 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
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

Study details

Start date: March 13, 2019
Primary completion date: June 1, 2029
Completion date: December 1, 2029
First posted: March 15, 2019

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT03876054
Registry last updated: January 7, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT03876054 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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