N/A
Completed N=134
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
Postoperative Pain · Back Pain
Source: ClinicalTrials.gov NCT02924129 ↗
Enrolled (actual)
134
Serious AEs
8.2%
Results posted
May 2021
Primary outcomePrimary: Number of Participants With Composite Endpoint Success — 51; 38 Participants — p=<0.001
Summary
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite Endpoint Success |
49; 36 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Leg Pain VAS Score |
72.9; 62.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Back Pain VAS Score |
69.4; 54.0 | <0.001 sig |
| SECONDARY Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score |
33; 22 | <0.001 sig |
| SECONDARY Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score |
47; 34 | <0.001 sig |
| SECONDARY Number of Participants With Composite Endpoint Success |
49; 36 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is male or female between the ages of 18 and 80 years.
- Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
- Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
- Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
Exclusion Criteria
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
- Have prior experience with SCS.
- Have an active systemic infection or local infection in the area of the surgical site.
- Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
- Be concomitantly participating in another clinical study.
Data sourced from ClinicalTrials.gov (NCT02924129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.