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Clinical Trials/NCT05272137
NCT05272137
Completed
Not 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 enrollmentFebruary 4, 2022
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ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Saluda Medical Pty Ltd
Enrollment
2
Locations
1
Primary Endpoint
ECAP Measurement in Microvolts
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
February 4, 2022
End Date
October 17, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Saluda Medical Pty Ltd
Responsible Party
Sponsor

Eligibility Criteria

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

Study Sites (1)

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