Clinical trial NCT03876054: Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Official title: Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: spinal cord stimulation
dorsal root ganglion stimulation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll adult male and female individuals scheduled to have an Abbott neurostimulation system implanted. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

Brief 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.

Detailed description: This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.

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.

Primary outcomes:
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: Baseline
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: Permanent Implant Procedure
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 6 months
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 9 months
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 1 Year
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 1.5 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 2 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 2.5 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 3 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 3.5 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 4 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 4.5 Years
measure: Rate of device and procedure related adverse events, deaths, and device deficiencies
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
timeFrame: 6 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
timeFrame: 1 Year
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
timeFrame: 2 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
timeFrame: 3 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
timeFrame: 4 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by PROMIS-29
timeFrame: 5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 6 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 9 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 1 year
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 1.5 years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 2 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 2.5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 3 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 3.5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 4 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 4.5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Numerical Rating Score (NRS)
timeFrame: 5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)
timeFrame: 6 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)
timeFrame: 1 Year
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)
timeFrame: 2 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)
timeFrame: 3 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)
timeFrame: 4 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Pain Catastrophizing Scale (PCS)
timeFrame: 5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)
timeFrame: 6 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)
timeFrame: 1 Year
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)
timeFrame: 2 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)
timeFrame: 3 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)
timeFrame: 4 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Oswestry Disability Index (ODI)
timeFrame: 5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage
timeFrame: 6 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage
timeFrame: 1 Year
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage
timeFrame: 2 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage
timeFrame: 3 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage
timeFrame: 4 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by pain condition-related medication usage
timeFrame: 5 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)
timeFrame: 6 months
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)
timeFrame: 1 Year
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)
timeFrame: 2 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)
timeFrame: 3 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)
timeFrame: 4 Years
measure: Mean Change in Clinical improvement from baseline to each follow up visit assessed by Transcutaneous Oxygen pressure measurement (TcPO2)
timeFrame: 5 Years
measure: Rate of patient satisfaction
timeFrame: 6 months
measure: Rate of patient satisfaction
timeFrame: 1 Year
measure: Rate of patient satisfaction
timeFrame: 2 Years
measure: Rate of patient satisfaction
timeFrame: 3 Years
measure: Rate of patient satisfaction
timeFrame: 4 Years
measure: Rate of patient satisfaction
timeFrame: 5 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 6 months
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 9 months
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 1 Year
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 1.5 Year
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 2 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 2.5 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 3 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 3.5 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 4 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 4.5 Years
measure: Rate of Patient Global Impression of Change (PGIC) for global improvement of the patient.
timeFrame: 5 Years
Locations:
city: Phoenix
country: United States
facility: Phoenician Centers for Research & Innovation
state: Arizona
city: Tucson
country: United States
facility: Pain Institute of Southern Arizona
state: Arizona
city: Larkspur
country: United States
facility: California Orthopedics & Spine
state: California
city: Orange
country: United States
facility: Restore Orthopedics & Spine Center
state: California
city: Pomona
country: United States
facility: Foothills Pain Management Clinic
state: California
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Gainesville
country: United States
facility: University of Florida Department of Anesthesia
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Edina
country: United States
facility: Nura
state: Minnesota
city: Edina
country: United States
facility: Twin Cities Pain Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: Saint Louis Pain Consultants
state: Missouri
city: Henderson
country: United States
facility: Advanced Pain Care
state: Nevada
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Rochester
country: United States
facility: Unity Spine Center
state: New York
city: Staten Island
country: United States
facility: The Spine & Pain Institute of New York
state: New York
city: Asheville
country: United States
facility: Premier Pain Solutions
state: North Carolina
city: Chillicothe
country: United States
facility: Adena Bone and Joint Center
state: Ohio
city: Loveland
country: United States
facility: Premier Pain Treatment Institute
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports & Spine
state: Oregon
city: Tualatin
country: United States
facility: Spinal Diagnostics
state: Oregon
city: Exton
country: United States
facility: Center for Interventional Pain & Spine
state: Pennsylvania
city: Houston
country: United States
facility: Expert Pain
state: Texas
city: Killeen
country: United States
facility: Central Texas Pain Institute
state: Texas
city: Killeen
country: United States
facility: Integrated Pain Associates
state: Texas
city: Round Rock
country: United States
facility: Advanced Pain Care
state: Texas
city: Charleston
country: United States
facility: The Spine & Nerve Center of St Francis Hospital
state: West Virginia
city: Clayton
country: Australia
facility: Metro Pain Group
state: Victoria
city: Kew
country: Australia
facility: Precision Brain, Spine & Pain Centre
state: Victoria
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Eflndrs
city: Roeselare
country: Belgium
facility: AZ Delta vzw
state: West Flanders
city: Tubingen
country: Germany
facility: Universitäts Klinikum Tübingen
state: Bad-wur
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt GmbH
state: Bavaria
city: Duisburg
country: Germany
facility: Klinikum Duisburg GmbH
state: N. Rhin
city: Dusseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
state: N. Rhin
city: Monchengladbach
country: Germany
facility: Krankenhaus Neuwerk Maria von den Aposteln
state: N. Rhin
city: Koln
country: Germany
facility: Kliniken der Stadt Köln-Merheim
state: North Rhine-Westphalia
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Gera
country: Germany
facility: Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
state: Thuringia
city: Koln
country: Germany
facility: Krankenhaus Porz am Rhein
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
state: Campani
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
state: Lombard
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: S Holln
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Cstleon
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Sion
country: Switzerland
facility: Hôpital du Valais
state: Valais
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
state: England
city: Liverpool
country: United Kingdom
facility: The Walton Centre
state: North West England
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: Sowest
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
state: Yorkshire And The Humber
Study officials:
affiliation: Abbott Medical Devices Neuromodulation
name: Devyani Nanduri
role: STUDY_DIRECTOR
References: