ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
NCT04319887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2024-12-31
Summary
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
Conditions
Interventions
- DEVICE
-
Evoke Spinal Cord Stimulation (SCS) System
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Sponsors & Collaborators
-
Saluda Medical Pty Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-29
- Primary Completion
- 2023-12-28
- Completion
- 2023-12-28
- FDA Device
- Yes
Countries
- United States
Study Locations
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