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Stimgenics Open-Label, Post Market Study

NCT03606187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2021-03-02

Study results available
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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.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

Stimgenics SCS Programming Approach

Stimgenics SCS Programming approach Using Intellis(TM) SCS system

DEVICE

Standard SCS Programming Approach

Standard SCS Programming approach using Intellis(TM) SCS system

Sponsors & Collaborators

  • Stimgenics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2019-11-08
Completion
2020-07-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606187 on ClinicalTrials.gov