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Stimgenics Open-Label, Post Market Study (SGX-SCS-RCT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606187
Recruitment Status : Completed
First Posted : July 30, 2018
Results First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Stimgenics LLC

Study Description
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Brief Summary:
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Stimgenics SCS Programming Approach Device: Standard SCS Programming Approach Not Applicable

Detailed Description:

This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard 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 SGX-SCS programming approach
  • Control treatment group with Standard 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : July 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test Arm
Subjects randomized to this arm will receive test treatment
 Device: Stimgenics SCS Programming Approach
Stimgenics SCS Programming approach Using Intellis(TM) SCS system
Active Comparator: Control Arm
Subjects randomized to this arm will receive control treatment
 Device: Standard SCS Programming Approach
Standard SCS Programming approach using Intellis(TM) SCS system


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Individual Responders [ Time Frame: 3 months ]
    Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS).


Secondary Outcome Measures :
  1. Percentage of Individual Responders [ Time Frame: 3 months ]
    The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority

  2. Change in Back Pain Score [ Time Frame: 3 months ]
    Comparison of change from Baseline in back pain score (using Visual Analog Scale 0.0-10.0cm) determined at the 3- and 6-month visit after device activation, between test and control in a statistical test of non-inferiority. This is calculated as: Change from Baseline in Back Pain VAS = 3-Month Visit Pain VAS - Baseline Pain VAS.

  3. 6 Months Comparison of Back Pain Treatment Success [ Time Frame: 6 months ]
    Comparison of Back Pain Treatment Success (responder rate), measured as subjects with at least a 50% reduction in Back Pain Visual Analog Scale (VAS), evaluated at 6 months after device activation, between test and control

  4. Oswestry Disability Index (ODI) [ Time Frame: 3 months ]
    Oswestry Disability Index (ODI) evaluated at 3 months visit

  5. Adverse Events [ Time Frame: 3 months ]
    Frequency of treatment emergent adverse events


Eligibility Criteria
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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 and leg pain)
  2. Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
  3. 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.
  4. Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
  5. Be 18 years of age or older at the time of enrollment
  6. Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
  7. Be willing to not increase pain medications from baseline through the 3-Month Visit
  8. Be willing and able to comply with study-related requirements, procedures, and visits

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. Be concurrently participating in another clinical study
  3. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
  4. 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
  5. Has mechanical spine instability as determined by the Investigator
Contacts and Locations
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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): NCT03606187


Locations
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United States, Illinois
StimGenics
Bloomington, Illinois, United States, 61701
Sponsors and Collaborators
Stimgenics LLC
  Study Documents (Full-Text)

Documents provided by Stimgenics LLC:
Study Protocol and Statistical Analysis Plan  [PDF] January 2, 2019

More Information
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Responsible Party: Stimgenics LLC
ClinicalTrials.gov Identifier: NCT03606187    
Other Study ID Numbers: SGEN-2018PM2
First Posted: July 30, 2018    Key Record Dates
Results First Posted: March 2, 2021
Last Update Posted: March 2, 2021
Last Verified: February 2021

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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
Keywords provided by Stimgenics LLC:
Back Pain, Spinal Cord Stimulation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations