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SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA) (NOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571242
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
SGX Medical LLC ( SGX Nova LLC )

Brief Summary:

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.


Condition or disease Intervention/treatment Phase
Back Pain Device: DTM Programming Device: Conventional SCS programming Not Applicable

Detailed Description:

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

  • Test treatment group with DTM-SCS programming approach
  • Control treatment group with Conventional SCS programming approach

Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.

Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization.

This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint.

The expected total duration of this study is approximately 32 months. Enrollment of subjects is expected to last 18 months. Subjects who have received the permanent implant will be followed up for approximately 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

  • Test treatment group with DTM-SCS programming approach
  • Control treatment group with Conventional SCS programming approach

Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: DTM-SCS program
This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test and Control treatments, which may identify the type of treatment to study participants. Also, open communication about sensation of paresthesia and pain relief is important in adjusting program parameters to provide optimal pain relief for participants. The assessments of device performance are done by the participants and not by the site personnel so the lack of blinding of site personnel should not affect results as pain is the major assessment and participants tend to describe pain truthfully since it affects their everyday life dramatically and not be influenced by knowledge of the device programming.
Device: DTM Programming
DTM-SCS programming

Active Comparator: Conventional SCS program
This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test and Control treatments, which may identify the type of treatment to study participants. Also, open communication about sensation of paresthesia and pain relief is important in adjusting program parameters to provide optimal pain relief for participants. The assessments of device performance are done by the participants and not by the site personnel so the lack of blinding of site personnel should not affect results as pain is the major assessment and subjects tend to describe pain truthfully since it affects their everyday life dramatically and not be influenced by knowledge of the device programming.
Device: Conventional SCS programming
Conventional SCS programming




Primary Outcome Measures :
  1. Percentage of implanted subjects who respond to DTM-SCS therapy compared to Conventional SCS therapy at 3-months [ Time Frame: 3 months ]
    The primary outcome measure is the percentage of randomized subjects who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be a candidate for SCS system (trial and implant) per labeled indication (back pain with or without leg pain)
  2. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
  3. Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of 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 regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study
  8. Be willing to not increase pain medications from baseline through the 3-Month Visit
  9. Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

  1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
  2. Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
  3. Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, as determined by the Investigator
  4. Be concurrently participating in another clinical study
  5. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc.
  6. Has a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
  7. Has mechanical spine instability as determined by the Investigator
  8. Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
  9. Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
  10. Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
  11. Be pregnant (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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571242


Contacts
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Contact: Laura Rudeen 650-208-5042 lrudeen@sgxmedical.com
Contact: Wesley Park 661-310-8409 wpark@sgxmedical.com

Locations
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United States, Illinois
SGX Medical Recruiting
Bloomington, Illinois, United States, 61704
Contact: Laura Rudeen    650-208-5042    lrudeen@sgxmedical.com   
Sponsors and Collaborators
SGX Nova LLC
Investigators
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Study Director: Laura Rudeen SGX Medical
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Responsible Party: SGX Nova LLC
ClinicalTrials.gov Identifier: NCT04571242    
Other Study ID Numbers: DTM-NOVA-2020PM1
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations