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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03876054




Registration number
NCT03876054
Ethics application status
Date submitted
12/03/2019
Date registered
15/03/2019
Date last updated
20/08/2024

Titles & IDs
Public title
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Scientific title
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
Secondary ID [1] 0 0
ABT-CIP-10279
Universal Trial Number (UTN)
Trial acronym
REALITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [2] 0 0
Permanent Implant Procedure
Primary outcome [3] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [4] 0 0
9 months
Primary outcome [5] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [5] 0 0
1 Year
Primary outcome [6] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [6] 0 0
1.5 Years
Primary outcome [7] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [7] 0 0
2 Years
Primary outcome [8] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [8] 0 0
2.5 Years
Primary outcome [9] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [9] 0 0
3 Years
Primary outcome [10] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [10] 0 0
3.5 Years
Primary outcome [11] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [11] 0 0
4 Years
Primary outcome [12] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [12] 0 0
4.5 Years
Primary outcome [13] 0 0
Rate of device and procedure related adverse events, deaths, and device deficiencies
Timepoint [13] 0 0
5 Years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Metro Pain Group - Clayton
Recruitment hospital [2] 0 0
Precision Brain, Spine & Pain Centre - Kew
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3101 - Kew
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
Belgium
State/province [16] 0 0
Eflndrs
Country [17] 0 0
Belgium
State/province [17] 0 0
West Flanders
Country [18] 0 0
Germany
State/province [18] 0 0
Bad-wur
Country [19] 0 0
Germany
State/province [19] 0 0
Bavaria
Country [20] 0 0
Germany
State/province [20] 0 0
N. Rhin
Country [21] 0 0
Germany
State/province [21] 0 0
North Rhine-Westphalia
Country [22] 0 0
Germany
State/province [22] 0 0
Schleswig-Holstein
Country [23] 0 0
Germany
State/province [23] 0 0
Thuringia
Country [24] 0 0
Germany
State/province [24] 0 0
Koln
Country [25] 0 0
Italy
State/province [25] 0 0
Campani
Country [26] 0 0
Italy
State/province [26] 0 0
Lombard
Country [27] 0 0
Netherlands
State/province [27] 0 0
S Holln
Country [28] 0 0
Netherlands
State/province [28] 0 0
Utrecht
Country [29] 0 0
Spain
State/province [29] 0 0
Cstleon
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Switzerland
State/province [32] 0 0
Valais
Country [33] 0 0
United Kingdom
State/province [33] 0 0
England
Country [34] 0 0
United Kingdom
State/province [34] 0 0
North West England
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Sowest
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Yorkshire And The Humber

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03876054
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Devyani Nanduri
Address 0 0
Abbott Medical Devices Neuromodulation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bram Blomme
Address 0 0
Country 0 0
Phone 0 0
+32 474 74 83 10
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03876054