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N/A Completed N=128 Randomized Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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