Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
NCT06499220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201
Last updated 2024-07-12
Summary
This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.
Conditions
Interventions
- DEVICE
-
Spinal Cord Stimulator
Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
Sponsors & Collaborators
-
MedtronicNeuro
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-30
- Primary Completion
- 2023-10-16
- Completion
- 2023-10-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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