Status:
COMPLETED
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Lead Sponsor:
SGX Procura LLC
Conditions:
Upper Limb
Pain
Eligibility:
All Genders
18+ years
Brief Summary
This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach. Data at follow-up visits will be compared t...
Detailed Description
This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach. Data at follow-up visits will be compared t...
Eligibility Criteria
Inclusion
- A subject must MEET ALL of the following inclusion criteria:
- Be diagnosed with chronic, intractable pain of the upper limb related to the cervical spine and/or neuropathic arm pain.
- Be a candidate for SCS system (trial and implant) per labeled indication (upper limb pain due to one of the conditions listed in indications statement)
- Considering daily activity and rest, has average upper limb pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- 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 written questionnaires, and read, understand and sign the written inform consent.
- 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 and able to comply with study -related requirements, procedures, and visits, including not increasing pain meds through the three month visit
- Has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
Exclusion
- A subject must NOT MEET ANY of the following exclusion criteria:
- Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
- Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the study manager or designee)
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump.
- 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 significant cervical stenosis, as determined by the Investigator
- Has facet spondylosis, as determined by the Investigator
- Has mechanical spine instability, as determined by the Investigator
- Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat upper limb pain, which is providing significant pain relief
- Has unresolved major issues of secondary gain (e.g., social, financial, legal, such as worker compensation matters)
- Be pregnant as determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.
- Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
- Have a current diagnosis of a progressive neurological disease as determined by the Investigator
- Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- Have a condition that the Investigator determines would significantly increase perioperative risk
- Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
- Have metastatic malignant disease or active local malignant disease
- Have a life expectancy of less than 1 year
- Have an active systemic or local infection
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
Key Trial Info
Start Date :
September 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04466111
Start Date
September 8 2020
End Date
March 9 2023
Last Update
August 19 2024
Active Locations (1)
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1
SGX Medical
Bloomington, Illinois, United States, 61704