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Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain (Freshwater)

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Evoke Spinal Cord Stimulation (SCS) System
Sponsored by
Saluda Medical Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Subject has the Evoke System implanted
  • 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion Criteria:

N/A

Sites / Locations

  • ACT Pain CentreRecruiting
  • Sydney Pain SpecialistsRecruiting
  • Genesis Research ServicesRecruiting
  • Northern Integrated Pain ManagementRecruiting
  • Australian Medical ResearchRecruiting
  • Inner West Pain CentreRecruiting
  • Royal North Shore HospitalRecruiting
  • Northern Pain CentreRecruiting
  • Women's Health & Research Institute of AustraliaRecruiting
  • Sydney Pain Research Centre Pty LtdRecruiting
  • Interventus Pain SpecialistsRecruiting
  • Axxon Pain MedicineRecruiting
  • QPAINRecruiting
  • Sunshine Coast Clinical ResearchRecruiting
  • Paul Frank Medical ServicesRecruiting
  • CerCare Pty LtdRecruiting
  • Monash Clinical ResearchRecruiting
  • Frankston Pain ManagementRecruiting
  • Pain MatrixRecruiting
  • Melbourne Pain SpecialistsRecruiting
  • Pain Specialists AustraliaRecruiting
  • PainCare PerthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECAP-controlled, closed-loop SCS

Arm Description

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Outcomes

Primary Outcome Measures

Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System

Secondary Outcome Measures

Full Information

First Posted
November 30, 2020
Last Updated
November 8, 2022
Sponsor
Saluda Medical Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04662905
Brief Title
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
Acronym
Freshwater
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saluda Medical Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 already implanted with the Evoke System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECAP-controlled, closed-loop SCS
Arm Type
Experimental
Arm Description
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Intervention Type
Device
Intervention Name(s)
Evoke Spinal Cord Stimulation (SCS) System
Intervention Description
ECAP-controlled, closed-loop SCS
Primary Outcome Measure Information:
Title
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Time Frame
Through study completion, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Subject has the Evoke System implanted 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements. Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director, Clinical Affairs
Phone
16512084223
Email
angela.leitner@saludamedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M Leitner
Organizational Affiliation
Saluda Medical Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
ACT Pain Centre
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Pain Specialists
City
Bella Vista
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
Individual Site Status
Recruiting
Facility Name
Genesis Research Services
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northern Integrated Pain Management
City
Charlestown
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Individual Site Status
Recruiting
Facility Name
Australian Medical Research
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Inner West Pain Centre
City
Newtown
State/Province
New South Wales
ZIP/Postal Code
2042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northern Pain Centre
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Women's Health & Research Institute of Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Pain Research Centre Pty Ltd
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Recruiting
Facility Name
Interventus Pain Specialists
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Name
Axxon Pain Medicine
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Individual Site Status
Recruiting
Facility Name
QPAIN
City
Fortitude Valley
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sunshine Coast Clinical Research
City
Noosa Heads
State/Province
Queensland
ZIP/Postal Code
4567
Country
Australia
Individual Site Status
Recruiting
Facility Name
Paul Frank Medical Services
City
Peregian Beach
State/Province
Queensland
ZIP/Postal Code
4573
Country
Australia
Individual Site Status
Recruiting
Facility Name
CerCare Pty Ltd
City
Wayville
State/Province
South Australia
ZIP/Postal Code
5034
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Clinical Research
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Frankston Pain Management
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Name
Pain Matrix
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Melbourne Pain Specialists
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Name
Pain Specialists Australia
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Name
PainCare Perth
City
Cottesloe
State/Province
Western Australia
ZIP/Postal Code
6011
Country
Australia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

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