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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04662905




Registration number
NCT04662905
Ethics application status
Date submitted
30/11/2020
Date registered
10/12/2020

Titles & IDs
Public title
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
Scientific title
A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
Secondary ID [1] 0 0
CLIN-PCL-007873
Universal Trial Number (UTN)
Trial acronym
Freshwater
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
Treatment: Devices - Evoke Spinal Cord Stimulation (SCS) System

Experimental: ECAP-controlled, closed-loop SCS - Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude


Treatment: Devices: Evoke Spinal Cord Stimulation (SCS) System
ECAP-controlled, closed-loop SCS
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Timepoint [1] 0 0
Through study completion, up to 2 years

Eligibility
Key inclusion criteria
* 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
* 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
ACT Pain Centre - Garran
Recruitment hospital [2] 0 0
Sydney Pain Specialists - Bella Vista
Recruitment hospital [3] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [4] 0 0
Northern Integrated Pain Management - Charlestown
Recruitment hospital [5] 0 0
Australian Medical Research - Hurstville
Recruitment hospital [6] 0 0
Inner West Pain Centre - Newtown
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [8] 0 0
Northern Pain Centre - St Leonards
Recruitment hospital [9] 0 0
Women's Health & Research Institute of Australia - Sydney
Recruitment hospital [10] 0 0
Sydney Pain Research Centre Pty Ltd - Wahroonga
Recruitment hospital [11] 0 0
Interventus Pain Specialists - Auchenflower
Recruitment hospital [12] 0 0
Axxon Pain Medicine - Brisbane
Recruitment hospital [13] 0 0
QPAIN - Fortitude Valley
Recruitment hospital [14] 0 0
Sunshine Coast Clinical Research - Noosa Heads
Recruitment hospital [15] 0 0
Paul Frank Medical Services - Peregian Beach
Recruitment hospital [16] 0 0
CerCare Pty Ltd - Wayville
Recruitment hospital [17] 0 0
Monash Clinical Research - Clayton
Recruitment hospital [18] 0 0
Frankston Pain Management - Frankston
Recruitment hospital [19] 0 0
Pain Matrix - Geelong
Recruitment hospital [20] 0 0
Melbourne Pain Specialists - Richmond
Recruitment hospital [21] 0 0
Pain Specialists Australia - Richmond
Recruitment hospital [22] 0 0
PainCare Perth - Cottesloe
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2153 - Bella Vista
Recruitment postcode(s) [3] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [4] 0 0
2290 - Charlestown
Recruitment postcode(s) [5] 0 0
2220 - Hurstville
Recruitment postcode(s) [6] 0 0
2042 - Newtown
Recruitment postcode(s) [7] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [8] 0 0
2065 - St Leonards
Recruitment postcode(s) [9] 0 0
2000 - Sydney
Recruitment postcode(s) [10] 0 0
2076 - Wahroonga
Recruitment postcode(s) [11] 0 0
4066 - Auchenflower
Recruitment postcode(s) [12] 0 0
4000 - Brisbane
Recruitment postcode(s) [13] 0 0
4006 - Fortitude Valley
Recruitment postcode(s) [14] 0 0
4567 - Noosa Heads
Recruitment postcode(s) [15] 0 0
4573 - Peregian Beach
Recruitment postcode(s) [16] 0 0
5034 - Wayville
Recruitment postcode(s) [17] 0 0
3168 - Clayton
Recruitment postcode(s) [18] 0 0
3199 - Frankston
Recruitment postcode(s) [19] 0 0
3220 - Geelong
Recruitment postcode(s) [20] 0 0
3121 - Richmond
Recruitment postcode(s) [21] 0 0
6011 - Cottesloe

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Saluda Medical Pty Ltd
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Angela M Leitner
Address 0 0
Saluda Medical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director, Clinical Affairs
Address 0 0
Country 0 0
Phone 0 0
16512084223
Fax 0 0
Email 0 0
angela.leitner@saludamedical.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/NCT04662905