Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
NCT ID: NCT03876054
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2019-03-13
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Spinal cord stimulation (SCS)
Subjects using Abbott SCS systems
Spinal cord stimulation (SCS)
Subjects will be implanted with market-released Abbott SCS systems
Dorsal root ganglion stimulation (DRG)
Subjects using Abbott DRG system
Dorsal root ganglion stimulation (DRG)
Subjects will be implanted with market-released Abbott DRG system
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Devyani Nanduri
Role: STUDY_DIRECTOR
Abbott Medical Devices Neuromodulation
Locations
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Phoenician Centers for Research & Innovation
Phoenix, Arizona, United States
Pain Institute of Southern Arizona
Tucson, Arizona, United States
California Orthopedics & Spine
Larkspur, California, United States
Restore Orthopedics & Spine Center
Orange, California, United States
Foothills Pain Management Clinic
Pomona, California, United States
Pacific Research Institute
Santa Rosa, California, United States
University of Florida Department of Anesthesia
Gainesville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Goodman Campbell Brain and Spine
Indianapolis, Indiana, United States
Nura
Edina, Minnesota, United States
Twin Cities Pain Clinic
Edina, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis Pain Consultants
Chesterfield, Missouri, United States
Advanced Pain Care
Henderson, Nevada, United States
Nevada Advanced Pain Specialists
Reno, Nevada, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Unity Spine Center
Rochester, New York, United States
The Spine & Pain Institute of New York
Staten Island, New York, United States
Premier Pain Solutions
Asheville, North Carolina, United States
Adena Bone and Joint Center
Chillicothe, Ohio, United States
Premier Pain Treatment Institute
Loveland, Ohio, United States
Pacific Sports & Spine
Eugene, Oregon, United States
Spinal Diagnostics
Tualatin, Oregon, United States
Center for Interventional Pain & Spine
Exton, Pennsylvania, United States
Expert Pain
Houston, Texas, United States
Central Texas Pain Institute
Killeen, Texas, United States
Integrated Pain Associates
Killeen, Texas, United States
Advanced Pain Care
Round Rock, Texas, United States
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, United States
Metro Pain Group
Clayton, Victoria, Australia
Precision Brain, Spine & Pain Centre
Kew, Victoria, Australia
AZ Nikolaas
Sint-Niklaas, Eflndrs, Belgium
AZ Delta vzw
Roeselare, West Flanders, Belgium
Universitäts Klinikum Tübingen
Tübingen, Bad-wur, Germany
Klinikum Ingolstadt GmbH
Ingolstadt, Bavaria, Germany
Krankenhaus Porz am Rhein
Cologne, Koln, Germany
Klinikum Duisburg GmbH
Duisburg, N. RHIN, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, N. RHIN, Germany
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach, N. RHIN, Germany
Kliniken der Stadt Köln-Merheim
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
Gera, Thuringia, Germany
Azienda Ospedaliera Monaldi
Napoli, Campani, Italy
Fondazione Salvatore Maugeri
Pavia, Lombard, Italy
Erasmus MC
Rotterdam, S Holln, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Hospital Universitario de Salamanca
Salamanca, Cstleon, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain
Hôpital du Valais
Sion, Valais, Switzerland
Norfolk and Norwich Hospital
Norwich, England, United Kingdom
The Walton Centre
Liverpool, North West England, United Kingdom
Southmead Hospital
Bristol, Sowest, United Kingdom
Seacroft Hospital
Leeds, Yorkshire and the Humber, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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ABT-CIP-10279
Identifier Type: -
Identifier Source: org_study_id
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