Freshwater: Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
Sponsor
Saluda Medical Pty Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04662905
Collaborator
(none)
150
20
1
36.5
7.5
0.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Dec 15, 2020
Anticipated Primary Completion Date
:
Jan 1, 2024
Anticipated Study Completion Date
:
Jan 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Device: Evoke Spinal Cord Stimulation (SCS) System
ECAP-controlled, closed-loop SCS
|
Outcome Measures
Primary Outcome Measures
- Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System [Through study completion, up to 2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- Subject has the Evoke System implanted
-
- Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Exclusion Criteria:
N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ACT Pain Centre | Garran | Australian Capital Territory | Australia | 2605 |
| 2 | Sydney Pain Specialists | Bella Vista | New South Wales | Australia | 2153 |
| 3 | Genesis Research Services | Broadmeadow | New South Wales | Australia | 2292 |
| 4 | Northern Integrated Pain Management | Charlestown | New South Wales | Australia | 2290 |
| 5 | Australian Medical Research | Hurstville | New South Wales | Australia | 2220 |
| 6 | Inner West Pain Centre | Newtown | New South Wales | Australia | 2042 |
| 7 | Royal North Shore Hospital | Saint Leonards | New South Wales | Australia | 2065 |
| 8 | Northern Pain Centre | St Leonards | New South Wales | Australia | 2065 |
| 9 | Women's Health & Research Institute of Australia | Sydney | New South Wales | Australia | 2000 |
| 10 | Sydney Pain Research Centre Pty Ltd | Wahroonga | New South Wales | Australia | 2076 |
| 11 | QPAIN | Fortitude Valley | Queensland | Australia | 4006 |
| 12 | Sunshine Coast Clinical Research | Noosa Heads | Queensland | Australia | 4567 |
| 13 | Paul Frank Medical Services | Peregian Beach | Queensland | Australia | 4573 |
| 14 | CerCare Pty Ltd | Wayville | South Australia | Australia | 5034 |
| 15 | Monash Clinical Research | Clayton | Victoria | Australia | 3168 |
| 16 | Frankston Pain Management | Frankston | Victoria | Australia | 3199 |
| 17 | Pain Matrix | Geelong | Victoria | Australia | 3220 |
| 18 | Melbourne Pain Specialists | Richmond | Victoria | Australia | 3121 |
| 19 | Pain Specialists Australia | Richmond | Victoria | Australia | 3121 |
| 20 | PainCare Perth | Cottesloe | Western Australia | Australia | 6011 |
Sponsors and Collaborators
- Saluda Medical Pty Ltd
Investigators
- Study Director: Angela M Leitner, Saluda Medical Pty Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Saluda Medical Pty Ltd
ClinicalTrials.gov Identifier:
NCT04662905
Other Study ID Numbers:
- CLIN-PCL-007873
First Posted:
Dec 10, 2020
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: