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Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain

CompletedNCT04466111
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain
Conditions
Interventions
  • Device: Intellis neurostimulator system
Sponsor
SGX Procura LLC
Organization
SGX Medical LLC
Start date
2020-09-08
Primary completion
2022-07-29
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * A subject must MEET ALL of the following inclusion criteria: 1. Be diagnosed with chronic, intractable pain of the upper limb related to the cervical spine and/or neuropathic arm pain. 2. 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) 3. 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 4. 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. 5. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent. 6. Be 18 years of age or older at the time of enrollment 7. Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study 8. Be willing and able to comply with study -related requirements, procedures, and visits, including not increasing pain meds through the three month visit 9. 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: 1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator 2. 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 3. 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) 4. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump. 5. 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 6. Has significant cervical stenosis, as determined by the Investigator 7. Has face…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04466111