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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm | Experimental | Subjects randomized to this arm will receive test treatment |
|
| Control Arm | Active Comparator | Subjects randomized to this arm will receive control treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimgenics SCS Programming Approach | Device | Stimgenics SCS Programming approach Using Intellis(TM) SCS system |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Individual Responders | 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Individual Responders | The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority | 3 months |
| Change in Back Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| StimGenics | Bloomington | Illinois | 61701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Arm | Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system |
| FG001 | Control Arm | Subjects randomized to this arm will receive control treatment Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Arm | Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Individual Responders | 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). | Intent to treat population (all subjects randomized) | Posted | Number | 90% Confidence Interval | percentage of responders | 3 months |
|
1 year
Adverse events related to the study is collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Arm | Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Affairs | SGX Medical | 6613108409 | wpark@sgxmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2019 | Nov 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard SCS Programming Approach | Device | Standard SCS Programming approach using Intellis(TM) SCS system |
|
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 months |
| 6 Months Comparison of Back Pain Treatment Success | 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 | 6 months |
| Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) evaluated at 3 months visit | 3 months |
| Adverse Events | Frequency of treatment emergent adverse events | 3 months |
Subjects randomized to this arm will receive control treatment
Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Back Pain | Visual Analog Score (0.0cm to 10.0cm line). Higher score represents more pain. | Mean | Standard Deviation | cm |
|
| Leg Pain | Visual Analog Score (0.0cm to 10.0cm). Higher score represents more pain. | Mean | Standard Deviation | cm |
|
Subjects randomized to this arm will receive test treatment
Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system
|
|
| Secondary | Percentage of Individual Responders | The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority | Not Posted | 3 months | Participants |
| Secondary | Change in Back Pain Score | 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. | Not Posted | 3 months | Participants |
| Secondary | 6 Months Comparison of Back Pain Treatment Success | 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 | Not Posted | 6 months | Participants |
| Secondary | Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) evaluated at 3 months visit | Not Posted | 3 months | Participants |
| Secondary | Adverse Events | Frequency of treatment emergent adverse events | Not Posted | 3 months | Participants |
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Control Arm | Subjects randomized to this arm will receive test treatment Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system | 0 | 61 | 2 | 61 | 0 | 61 |
| Medical device site pain | General disorders | MedDRA | Systematic Assessment |
|
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