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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/NCT04662905




Registration number
NCT04662905
Ethics application status
Date submitted
30/11/2020
Date registered
10/12/2020
Date last updated
12/12/2023

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
N/A
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
The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled
closed loop SCS through the incorporation of new software and/or hardware features for
patients with the Evoke System.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04662905
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04662905