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

NCT04466111 | Completed Results FDA Device

• 1 other identifier: DTM-PROC-2020PM3
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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 to baseline assessments collected at the beginning of the study.

Conditions

Upper Limb; Pain

Keywords

upper limb; Spinal Cord Stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Intellis neurostimulator system DEVICE

The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.

Also known as: Spinal Cord Stimulation (SCS) device system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• SGX Procura LLC: lead

Study Sites (1)

SGX Medical

Bloomington, Illinois, 61704, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Spinal Cord Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drug Therapy

Results Point of Contact

• Title: VP of Clinical
• Organization: SGX Medical

clinical@sgxmedical.com

818-527-2710

Study Officials

• Ricardo Vallejo, MD

  SGX Medical

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: September 8, 2020
• Primary Completion: July 29, 2022
• Study Completion: March 9, 2023
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Locations

US (1)