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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03876054
Registration number
NCT03876054
Ethics application status
Date submitted
12/03/2019
Date registered
15/03/2019
Date last updated
9/01/2024
Titles & IDs
Public title
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
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Scientific title
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
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Secondary ID [1]
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ABT-CIP-10279
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Universal Trial Number (UTN)
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Trial acronym
REALITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Spinal cord stimulation (SCS)
Treatment: Devices - Dorsal root ganglion stimulation (DRG)
Spinal cord stimulation (SCS) - Subjects using Abbott SCS systems
Dorsal root ganglion stimulation (DRG) - Subjects using Abbott DRG system
Treatment: Devices: Spinal cord stimulation (SCS)
Subjects will be implanted with market-released Abbott SCS systems
Treatment: Devices: Dorsal root ganglion stimulation (DRG)
Subjects will be implanted with market-released Abbott DRG system
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [2]
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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.
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Timepoint [2]
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Permanent Implant Procedure
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Primary outcome [3]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [3]
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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.
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Timepoint [3]
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6 months
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Primary outcome [4]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [4]
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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.
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Timepoint [4]
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9 months
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Primary outcome [5]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [5]
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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.
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Timepoint [5]
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1 Year
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Primary outcome [6]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [6]
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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.
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Timepoint [6]
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1.5 Years
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Primary outcome [7]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [7]
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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.
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Timepoint [7]
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2 Years
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Primary outcome [8]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [8]
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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.
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Timepoint [8]
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2.5 Years
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Primary outcome [9]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [9]
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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.
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Timepoint [9]
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3 Years
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Primary outcome [10]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [10]
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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.
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Timepoint [10]
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3.5 Years
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Primary outcome [11]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [11]
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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.
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Timepoint [11]
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4 Years
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Primary outcome [12]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [12]
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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.
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Timepoint [12]
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4.5 Years
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Primary outcome [13]
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Rate of device and procedure related adverse events, deaths, and device deficiencies
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Assessment method [13]
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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.
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Timepoint [13]
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5 Years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2029
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Metro Pain Group - Clayton
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Recruitment hospital [2]
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Precision Brain, Spine & Pain Centre - Kew
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3101 - Kew
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Indiana
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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Nevada
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Country [9]
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United States of America
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State/province [9]
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New York
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Country [10]
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United States of America
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State/province [10]
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North Carolina
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Country [11]
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United States of America
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State/province [11]
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Ohio
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Country [12]
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United States of America
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State/province [12]
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Oregon
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Country [13]
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United States of America
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State/province [13]
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Pennsylvania
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Country [14]
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United States of America
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State/province [14]
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Texas
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Country [15]
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United States of America
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State/province [15]
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West Virginia
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Country [16]
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Belgium
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State/province [16]
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Eflndrs
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Country [17]
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Belgium
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State/province [17]
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West Flanders
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Country [18]
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Germany
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State/province [18]
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Bad-wur
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Country [19]
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Germany
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State/province [19]
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Bavaria
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Country [20]
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Germany
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State/province [20]
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N. Rhin
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Country [21]
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Germany
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State/province [21]
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North Rhine-Westphalia
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Country [22]
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Germany
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State/province [22]
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Schleswig-Holstein
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Country [23]
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Germany
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State/province [23]
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Thuringia
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Country [24]
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Germany
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Koln
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Country [25]
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Italy
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Campani
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Italy
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State/province [26]
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Lombard
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Country [27]
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Netherlands
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S Holln
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Country [28]
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Netherlands
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State/province [28]
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Utrecht
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Spain
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State/province [29]
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Cstleon
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Country [30]
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Spain
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State/province [30]
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Madrid
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Spain
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State/province [31]
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Valencia
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Country [32]
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Switzerland
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State/province [32]
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Valais
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Country [33]
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United Kingdom
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State/province [33]
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England
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Country [34]
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United Kingdom
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North West England
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Country [35]
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United Kingdom
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State/province [35]
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Sowest
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Country [36]
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United Kingdom
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State/province [36]
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Yorkshire And The Humber
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03876054
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Devyani Nanduri
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Address
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Abbott Medical Devices Neuromodulation
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Udoka Okaro
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Address
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Country
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Phone
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+1 512 286 4258
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03876054
Download to PDF