Stimgenics Open-Label, Post Market Study

NCT ID: NCT03606187

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2020-07-22

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Arm

Subjects randomized to this arm will receive test treatment

Group Type: EXPERIMENTAL

Stimgenics SCS Programming Approach

Intervention Type: DEVICE

Stimgenics SCS Programming approach Using Intellis(TM) SCS system

Control Arm

Subjects randomized to this arm will receive control treatment

Group Type: ACTIVE_COMPARATOR

Standard SCS Programming Approach

Intervention Type: DEVICE

Standard SCS Programming approach using Intellis(TM) SCS system

Interventions

Stimgenics SCS Programming Approach

Stimgenics SCS Programming approach Using Intellis(TM) SCS system

Intervention Type: DEVICE

Standard SCS Programming Approach

Standard SCS Programming approach using Intellis(TM) SCS system

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stimgenics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

StimGenics

Bloomington, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SGEN-2018PM2

Identifier Type: -

Identifier Source: org_study_id