Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain (PROC2020PM)

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

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 Overview

• Status: Completed
• Conditions: Pain; Upper Limb
• Intervention / Treatment: Device: Intellis neurostimulator system

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 to baseline assessments collected at the beginning of the study.

The expected total duration of this study is approximately 26 months. Enrollment of participants is expected to last 20 months. Participants that have received the permanent implant will be followed up for 12 months after their device has been activated. A participant will likely be committed to the study for about 14 months. This consists of Baseline assessments, up to 10 days of trial stimulation, and 12 months of treatment following implantation and activation of the device. All subjects who plan on remaining implanted through the 6-month visit or who have completed their 6-month visit will be offered to return for an additional 12-month visit. This would increase their commitment to the study to 14 months.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • SGX Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The intended study population is individuals who have been diagnosed with chronic, intractable pain of the upper limbs associated with a number of conditions, and who the Principal Investigator deems is an appropriate candidate for SCS therapy as required for this study.

Description

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 facet spondylosis, as determined by the Investigator
  8. Has mechanical spine instability, as determined by the Investigator
  9. 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
  10. Has unresolved major issues of secondary gain (e.g., social, financial, legal, such as worker compensation matters)
  11. 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.
  12. Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
  13. Have a current diagnosis of a progressive neurological disease as determined by the Investigator
  14. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
  15. Have a condition that the Investigator determines would significantly increase perioperative risk
  16. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
  17. Have metastatic malignant disease or active local malignant disease
  18. Have a life expectancy of less than 1 year
  19. Have an active systemic or local infection
  20. 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of implanted subjects who respond to DTM SCS therapy at 3-months	The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.	3 months

Collaborators and Investigators

• Sponsor: SGX Procura LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain; upper limb; Spinal Cord Stimulation
• Other Study ID Numbers: DTM-PROC-2020PM3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No