NCT03606187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 2, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

July 12, 2018

Results QC Date

November 8, 2020

Last Update Submit

February 10, 2021

Conditions

Chronic Low Back Pain

Keywords

Back Pain, Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Percentage of Individual Responders

    3 months

  • Change in Back Pain Score

    3 months

  • 6 Months Comparison of Back Pain Treatment Success

    6 months

  • Oswestry Disability Index (ODI)

    3 months

  • Adverse Events

    3 months

Study Arms (2)

Test Arm

EXPERIMENTAL

Subjects randomized to this arm will receive test treatment

Device: Stimgenics SCS Programming Approach

Control Arm

ACTIVE COMPARATOR

Subjects randomized to this arm will receive control treatment

Device: Standard SCS Programming Approach

Interventions

Stimgenics SCS Programming ApproachDEVICE

Stimgenics SCS Programming approach Using Intellis(TM) SCS system

Test Arm
Standard SCS Programming ApproachDEVICE

Standard SCS Programming approach using Intellis(TM) SCS system

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StimGenics

Bloomington, Illinois, 61701, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
VP of Clinical Affairs
Organization
SGX Medical
wpark@sgxmedical.com
6613108409

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 30, 2018

Study Start

June 26, 2018

Primary Completion

November 8, 2019

Study Completion

July 22, 2020

Last Updated

March 2, 2021

Results First Posted

March 2, 2021

Record last verified: 2021-02

Locations

US(1)