Stimgenics Open-Label, Post Market Study

Completed · Not applicable

Conditions studied: Chronic Low Back Pain

In brief

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.

Key facts

Study ID

NCT03606187

Run by

Stimgenics LLC

People needed

128

Starts

2018-06-26

Expected to finish

2020-07-22

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• StimGenics — Bloomington, Illinois, United States

Full record on ClinicalTrials.gov

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