Clinical trial NCT04662905: Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
timeFrame: Through study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Garran
country: Australia
facility: ACT Pain Centre
state: Australian Capital Territory
city: Bella Vista
country: Australia
facility: Sydney Pain Specialists
state: New South Wales
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Charlestown
country: Australia
facility: Northern Integrated Pain Management
state: New South Wales
city: Hurstville
country: Australia
facility: Australian Medical Research
state: New South Wales
city: Newtown
country: Australia
facility: Inner West Pain Centre
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Pain Centre
state: New South Wales
city: Sydney
country: Australia
facility: Women's Health & Research Institute of Australia
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Pain Research Centre Pty Ltd
state: New South Wales
city: Auchenflower
country: Australia
facility: Interventus Pain Specialists
state: Queensland
city: Brisbane
country: Australia
facility: Axxon Pain Medicine
state: Queensland
city: Brisbane
country: Australia
facility: Total Pain Clinic
state: Queensland
city: Fortitude Valley
country: Australia
facility: QPAIN
state: Queensland
city: Noosa Heads
country: Australia
facility: Sunshine Coast Clinical Research
state: Queensland
city: Peregian Beach
country: Australia
facility: Paul Frank Medical Services
state: Queensland
city: Wayville
country: Australia
facility: CerCare Pty Ltd
state: South Australia
city: Clayton
country: Australia
facility: Monash Clinical Research
state: Victoria
city: Frankston
country: Australia
facility: Frankston Pain Management
state: Victoria
city: Geelong
country: Australia
facility: Pain Matrix
state: Victoria
city: Richmond
country: Australia
facility: Melbourne Pain Specialists
state: Victoria
city: Richmond
country: Australia
facility: Pain Specialists Australia
state: Victoria
city: Cottesloe
country: Australia
facility: PainCare Perth
state: Western Australia
Study officials:
affiliation: Saluda Medical Pty Ltd
name: Angela M Leitner
role: STUDY_DIRECTOR
References: