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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04683718




Registration number
NCT04683718
Ethics application status
Date submitted
21/12/2020
Date registered
24/12/2020

Titles & IDs
Public title
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management
Scientific title
BENEFIT-03 Clinical Study
Secondary ID [1] 0 0
BENEFIT-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low-back Pain 0 0
Chronic Leg Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management

Experimental: BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System - Eligible participants will be permanently implanted with a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management.


Treatment: Devices: Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management
The Prospera SCS System is a rechargeable, 16-electrode, MRI conditional Spinal Cord Stimulation system that delivers electrical stimulation to the dorsal column of the spinal cord for the treatment of chronic intractable pain of the trunk and/or limbs.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy
Timepoint [1] 0 0
6 months post-implant
Primary outcome [2] 0 0
Primary Safety Information on the BIOTRONIK Prospera SCS System
Timepoint [2] 0 0
6 months post-implant

Eligibility
Key inclusion criteria
* Currently indicated for SCS therapy for the treatment of low back and/or leg pain
* Planned permanent implant of BIOTRONIK's Prospera SCS System with HomeStream Remote Management
* Planned placement of two BIOTRONIK Resilience SCS trial leads
* Documented scores of = 60 mm out of 100 mm on the Visual Analog Scale (VAS) for both overall pain intensity and pain intensity in the index area of pain, assessed at the time of enrollment
* Willing and able to comply with all study requirements, including all required procedures, phone and/or video calls, and study visits
* Age greater than or equal to 18 years and less than 80 years
* Able to understand the nature of the study and provide written informed consent
* Able to read, understand, and speak English
* Patient's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Oswestry Disability Index (ODI) score of 41 to 80 out of 100
* Passed psychological evaluation
* For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result = 8.0%
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any contraindication for SCS therapy
* Patients with an implanted pacemaker, defibrillator, or any other medical contraindication for SCS therapy
* Currently implanted with an infusion pump or any implantable neurostimulator device
* Previously implanted with a neurostimulation system or prior participation in a trial period for a neurostimulation system
* Currently enrolled in any investigational device or drug trial for the management of chronic pain
* Patients who have undergone spinal surgery within 12 months prior to enrollment
* Patients currently involved in an active WorkCover insurance claim and/or active litigation related to injury associated with indication for SCS
* Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to enrollment
* Patients currently displaying opioid-seeking behavior
* Presence of any life-threatening, underlying illness
* Life expectancy less than 1 year
* Patients reporting pregnancy at the time of enrollment or intending to become pregnant during the 2-year study duration
* Patients with opioid dosages > 120 morphine milligram equivalents (MME) per day
* Patients with poor compliance for pain management regimen
* Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator
* Patients with pain originating from peripheral vascular disease
* Current diagnosis of a coagulation disorder or bleeding diathesis
* Patients with a diagnosis of severe thoracic scoliosis that is likely to preclude SCS lead placement
* Patients who are immunocompromised and/or at high risk for infection
* Patients with a documented history of allergic response or sensitivity to material(s) required for the study (e.g. adhesives, titanium, silicone, etc.)

At the conclusion of the trial period, the absence of the following exclusion criteria should be confirmed before proceeding with the permanent Prospera SCS System implant:

* Reduction in overall pain of less than 50% from baseline, assessed using VAS
* Unsuccessful trial period as otherwise determined by the investigator
* Determined by the investigator to be a poor candidate for permanent Prospera SCS System implant per standard of care (e.g. due to infection, non-compliance with pain medication regimen, paresis, clumsiness, numbness, and other)

Additionally, pre-operative screening for staphylococcus aureus (MRSA/MSSA) must be conducted after the SCS trial period and prior to implantation of the permanent device.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Australian Medical Research - Hurstville
Recruitment hospital [3] 0 0
Sydney Pain Research Centre - Wahroonga
Recruitment hospital [4] 0 0
Sunshine Coast Clinical Research - Noosa Heads
Recruitment hospital [5] 0 0
Monash Clinical Research - Clayton
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
4567 - Noosa Heads
Recruitment postcode(s) [5] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biotronik Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
BIOTRONIK Neuro
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Verrills, MD
Address 0 0
Metro Pain Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Justin Michalski
Address 0 0
Country 0 0
Phone 0 0
(503)927-7230
Fax 0 0
Email 0 0
benefit03@biotronik.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04683718