NCT05272137CompletedNot Applicable
Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical's Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs
Saluda Medical Pty Ltd1 site in 1 country2 target enrollmentStarted: February 4, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- ECAP Measurement in Microvolts
Study Overview
Brief Summary
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient approval for data collection and transfer of de-identified data to sponsor.
Exclusion Criteria
- •No further exclusion criteria.
Outcomes
Primary Outcomes
ECAP Measurement in Microvolts
Time Frame: through 6 months post-implant
Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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