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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02143791




Registration number
NCT02143791
Ethics application status
Date submitted
19/05/2014
Date registered
21/05/2014
Date last updated
8/07/2024

Titles & IDs
Public title
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
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.
Secondary ID [1] 0 0
NM-13-038-ID-SC
Universal Trial Number (UTN)
Trial acronym
Prodigy-I
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
Interventional
Description of intervention(s) / exposure
Experimental: Burst and Tonic stimulation - All subjects were required to receive BurstDR stimulation therapy for the first 3 months after permanent implant. Thereafter the stimulation mode could be changed to tonic stimulation depending on patient's preference or physician's discretion.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Change From Baseline in Overall VAS at 3 Months
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Pain Relief
Timepoint [1] 0 0
3 Months
Secondary outcome [2] 0 0
Pain Relief
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Pain Relief
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
Change in Pain Catastrophizing Scale
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
Number of Participants With Analgesic Reduction
Timepoint [5] 0 0
12 Months
Secondary outcome [6] 0 0
Change in Quality of Life
Timepoint [6] 0 0
Baseline and 12 Months
Secondary outcome [7] 0 0
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Timepoint [7] 0 0
from enrollment to 12 months follow up
Secondary outcome [8] 0 0
Paresthesia Mapping at 3 Months Compared to the Empower Study
Timepoint [8] 0 0
3 Months

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 diagnosed with radiculopathy
* Patient diagnosed with neuropathic 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is diagnosed with ischemic pain
* Patient is diagnosed with arachnoiditis
* Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
* Patient is diagnosed with peripheral vascular disease (PVD)
* Patient is diagnosed with diabetic neuropathic pain
* Patient is diagnosed with chronic migraine
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Metro Spinal Clinic - Caulfield
Recruitment hospital [2] 0 0
Frankston Pain Management - Frankston
Recruitment hospital [3] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
3162 - Caulfield
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Germany
State/province [2] 0 0
Duesseldorf
Country [3] 0 0
Germany
State/province [3] 0 0
Gera
Country [4] 0 0
Germany
State/province [4] 0 0
Köln
Country [5] 0 0
Germany
State/province [5] 0 0
Magdeburg
Country [6] 0 0
Germany
State/province [6] 0 0
Tubingen
Country [7] 0 0
Ireland
State/province [7] 0 0
Dublin
Country [8] 0 0
Italy
State/province [8] 0 0
Napoli
Country [9] 0 0
Italy
State/province [9] 0 0
Pisa
Country [10] 0 0
Italy
State/province [10] 0 0
Roma
Country [11] 0 0
Netherlands
State/province [11] 0 0
Enschede
Country [12] 0 0
Netherlands
State/province [12] 0 0
Nieuwegein
Country [13] 0 0
Netherlands
State/province [13] 0 0
Velp
Country [14] 0 0
Spain
State/province [14] 0 0
Sevilla
Country [15] 0 0
Sweden
State/province [15] 0 0
Uppsala
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Leeds
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Middlesbrough

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02143791
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tony Van Havenbergh
Address 0 0
St Augustinus, Wilrijk, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02143791