A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Succsessful Use of APM
Study Overview
Brief Summary
Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
- •Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Exclusion Criteria
- •There are no exclusion criteria.
Arms & Interventions
APM
Investigational programming software module, the Assisted Programming Module (APM)
Intervention: Evoke Spinal Cord Stimulation System (Device)
Outcomes
Primary Outcomes
Succsessful Use of APM
Time Frame: All timepoints through study completion, on average 3-months post-implant procedure.
Of all APM uses, the workflow was able to generate a closed-loop program 134 (96%) times.
Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
Time Frame: end of trial period; 1 month and 3 months post-implant
Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System
Time Frame: end of trial period; 1 month and 3 months post-implant
Change in programming parameters (e.g., stimulation frequency \[Hz\], pulse width \[µs\], amplitude \[mA\]) measured by the Evoke SCS System
Secondary Outcomes
- Time to Generate APM Program When Closed-loop Program Achieved(All uses through study completion in which APM was initiated)