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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

Tracking Information
First Submitted Date  ICMJE July 12, 2018
First Posted Date  ICMJE July 30, 2018
Results First Submitted Date  ICMJE November 8, 2020
Results First Posted Date  ICMJE March 2, 2021
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
The percentage of Individual Responders in the test group is shown to be statistically non-inferior to the percentage in the control group. [ Time Frame: 3 months ]
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2021)
  • 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
  • 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.
  • 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
  • Oswestry Disability Index (ODI) [ Time Frame: 3 months ]
    Oswestry Disability Index (ODI) evaluated at 3 months visit
  • Adverse Events [ Time Frame: 3 months ]
    Frequency of treatment emergent adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • Comparison of the percentage of Individual Responders between the test and control groups in a statistical test of superiority [ Time Frame: 3, 6 months ]
    The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale) in the test group is shown to be statistically superior to the percentage in the control group.
  • Comparison of change from Baseline in back pain score based on Visual Analog Scale (VAS) [ Time Frame: 3, 6 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.
  • 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
  • Comparison of mean change from Baseline in disability as measured by Oswestry Disability Index (ODI), evaluated at 3 months after device activation between test and control [ Time Frame: 3, 6 months ]
  • Frequency of treatment emergent adverse events [ Time Frame: 3, 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stimgenics Open-Label, Post Market Study
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Device: Stimgenics SCS Programming Approach
    Stimgenics SCS Programming approach Using Intellis(TM) SCS system
  • Device: Standard SCS Programming Approach
    Standard SCS Programming approach using Intellis(TM) SCS system
Study Arms  ICMJE
  • Experimental: Test Arm
    Subjects randomized to this arm will receive test treatment
    Intervention: Device: Stimgenics SCS Programming Approach
  • Active Comparator: Control Arm
    Subjects randomized to this arm will receive control treatment
    Intervention: Device: Standard SCS Programming Approach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2021)
128
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2018)
250
Actual Study Completion Date  ICMJE July 22, 2020
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03606187
Other Study ID Numbers  ICMJE SGEN-2018PM2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stimgenics LLC
Study Sponsor  ICMJE Stimgenics LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stimgenics LLC
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP