N/A
N=58
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Upper Limb · Pain
Bottom Line
View on ClinicalTrials.gov: NCT04466111 ↗Enrolled (actual)
58
Serious AEs
1.7%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months — 100 percentage of individual responder
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Intellis neurostimulator system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SGX Procura LLC
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Implanted Subjects Who Respond to DTM SCS Therapy at 3-months |
100 | — |
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 to baseline assessments collected at the beginning of the study.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04466111). 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.