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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04662905

Acronym

Freshwater

Enrollment

200

Registered

2020-12-10

Start date

2020-12-15

Completion date

2027-01-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

DEVICEEvoke Spinal Cord Stimulation (SCS) System

ECAP-controlled, closed-loop SCS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System	Through study completion, up to 2 years

Countries

Australia

Contacts

CONTACTDirector, Clinical Affairs

angela.leitner@saludamedical.com16512084223

STUDY_DIRECTORAngela M Leitner

Saluda Medical Pty Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026