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

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stimgenics SCS Programming Approach

Standard SCS Programming Approach

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Back Pain, Spinal Cord Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
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
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.
Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
Be 18 years of age or older at the time of enrollment
Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
Be willing to not increase pain medications from baseline through the 3-Month Visit
Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
Be concurrently participating in another clinical study
Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
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
Has mechanical spine instability as determined by the Investigator

Sites / Locations

StimGenics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Arm

Control Arm

Arm Description

Subjects randomized to this arm will receive test treatment

Subjects randomized to this arm will receive control treatment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percentage of Individual Responders

The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority

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.

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

Oswestry Disability Index (ODI)

Oswestry Disability Index (ODI) evaluated at 3 months visit

Adverse Events

Frequency of treatment emergent adverse events

Full Information

NCT ID

NCT03606187

First Posted

July 12, 2018

Last Updated

February 10, 2021

Sponsor

Stimgenics LLC

1. Study Identification

Unique Protocol Identification Number

NCT03606187

Brief Title

Stimgenics Open-Label, Post Market Study

Acronym

SGX-SCS-RCT

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

June 26, 2018 (Actual)

Primary Completion Date

November 8, 2019 (Actual)

Study Completion Date

July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stimgenics LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

Back Pain, Spinal Cord Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Arm

Arm Type

Experimental

Arm Description

Subjects randomized to this arm will receive test treatment

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

Subjects randomized to this arm will receive control treatment

Intervention Type

Device

Intervention Name(s)

Stimgenics SCS Programming Approach

Intervention Description

Stimgenics SCS Programming approach Using Intellis(TM) SCS system

Intervention Type

Device

Intervention Name(s)

Standard SCS Programming Approach

Intervention Description

Standard SCS Programming approach using Intellis(TM) SCS system

Primary Outcome Measure Information:

Title

The Percentage of Individual Responders

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Percentage of Individual Responders

Description

The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority

Time Frame

3 months

Title

Change in Back Pain Score

Description

Time Frame

3 months

Title

6 Months Comparison of Back Pain Treatment Success

Description

Time Frame

6 months

Title

Oswestry Disability Index (ODI)

Description

Oswestry Disability Index (ODI) evaluated at 3 months visit

Time Frame

3 months

Title

Adverse Events

Description

Frequency of treatment emergent adverse events

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain) 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 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. Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English. Be 18 years of age or older at the time of enrollment Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study Be willing to not increase pain medications from baseline through the 3-Month Visit Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator Be concurrently participating in another clinical study Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc. 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 Has mechanical spine instability as determined by the Investigator

Facility Information:

Facility Name

StimGenics

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61701

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Stimgenics Open-Label, Post Market Study

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