N/A
Completed N=128
Stimgenics Open-Label, Post Market Study
Source: ClinicalTrials.gov NCT03606187 ↗Enrolled (actual)
128
Serious AEs
1.6%
Results posted
Mar 2021
Primary outcomePrimary: The Percentage of Individual Responders — 80.9; 50.9 percentage of responders
Summary
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Individual Responders |
80.9; 50.9 | — |
| SECONDARY Percentage of Individual Responders |
— | — |
| SECONDARY Change in Back Pain Score |
— | — |
| SECONDARY 6 Months Comparison of Back Pain Treatment Success |
— | — |
| SECONDARY Oswestry Disability Index (ODI) |
— | — |
| SECONDARY Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
- Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
- Be 18 years of age or older at the time of enrollment
- Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
- Be willing to not increase pain medications from baseline through the 3-Month Visit
- Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion Criteria
- Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
- Has mechanical spine instability as determined by the Investigator
Data sourced from ClinicalTrials.gov (NCT03606187). 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.