Stimgenics Open-Label, Post Market Study (SGX-SCS-RCT)
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|ClinicalTrials.gov Identifier: NCT03606187|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Device: Stimgenics SCS Programming Approach Device: Standard SCS Programming Approach||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||March 2020|
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
- 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).
- 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 ]
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
|United States, Illinois|
|Bloomington, Illinois, United States, 61701|