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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/NCT02143791
Registration number
NCT02143791
Ethics application status
Date submitted
19/05/2014
Date registered
21/05/2014
Date last updated
11/11/2016
Titles & IDs
Public title
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
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Scientific title
A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
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Secondary ID [1]
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NM-13-038-ID-SC
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Universal Trial Number (UTN)
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Trial acronym
Prodigy-I
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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: Surgery - Burst stimulation
Treatment: Devices - Prodigy system
Burst stimulation - At permanent implant with the Prodigy system, patients will be programmed with Burst stimulation
Treatment: Surgery: Burst stimulation
Treatment: Devices: Prodigy system
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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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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The primary endpoint is the percentage of pain relief at the 3-month visit compared to baseline visit, as measured by the Visual Analog Scale (VAS).
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Assessment method [1]
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Rate of serious adverse events (SAEs) and/or procedure/device-related adverse events ((S)ADEs)
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Assessment method [1]
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Timepoint [1]
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from enrollment to 12 months follow up
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Eligibility
Key inclusion criteria
- Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral
or bilateral pain associated with the following: failed back surgery syndrome or
intractable low back and/or leg pain
- Patient is considered by the investigator as a candidate for implantation of a SCS
system
- Patient is = 18 years of age
- Patient must be willing and able to comply with study requirements
- Patient must indicate his/her understanding of the study and willingness to
participate by signing an appropriate Informed Consent Form
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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?
No
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Key exclusion criteria
- Patient is immune-compromised
- Patient has history of cancer requiring active treatment in the last 6 months
- Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or
substance dependency in the last 6 months
- Patients with a SCS system or implantable infusion pump implanted previously
- Patient has a life expectancy of less than one year
- Patient is pregnant or is planning to become pregnant during the duration of the
investigation
- Patient is unable to comply with the follow up schedule
- Patient needing legally authorized representative
- Patient unable to read and write
- Patient is currently participating in another clinical investigation with an active
treatment arm
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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
Completed
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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
1/06/2014
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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
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Actual
1/10/2016
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Metro Spinal Clinic - Caulfield
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Recruitment hospital [2]
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Frankston Pain Management - Frankston
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Recruitment hospital [3]
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Epworth Hospital - Richmond
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Recruitment postcode(s) [1]
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3162 - Caulfield
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Recruitment postcode(s) [2]
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- Frankston
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Recruitment postcode(s) [3]
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- Richmond
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Antwerp
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Germany
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Duesseldorf
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Germany
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Gera
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Germany
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Köln
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Germany
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Magdeburg
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Germany
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Tubingen
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Ireland
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Dublin
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Italy
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Napoli
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Italy
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Pisa
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Italy
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Roma
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Netherlands
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Enschede
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Netherlands
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Nieuwegein
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Netherlands
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Velp
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Spain
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Sevilla
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Sweden
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State/province [15]
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Uppsala
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United Kingdom
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Leeds
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United Kingdom
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London
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Country [18]
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United Kingdom
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State/province [18]
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Middlesbrough
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM
neuromodulation system in the management of failed back surgery syndrome or chronic
intractable pain of the trunk and/or limbs.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02143791
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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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Tony Van Havenbergh
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Address
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St Augustinus, Wilrijk, Belgium
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02143791
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