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SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

NCT04054401·2 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Gabi Molnar
CONTACT
612-217-2914 Gabi@SynerFuse.com

Lead

SynerFuse, Inc

Age

21–80

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy
Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months
At least 6 months since last surgical procedure on the spine
Be 21 years of age or older at the time of enrollment
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements

You may not be if

Any prior spinal fusion at index or adjacent level
Pregnant
Have a life expectancy of less than 1 year
Be concomitantly participating in another clinical study
Be involved in an injury claim under current litigation
Baseline narcotic use of ≥ 100 MME per day
Significant untreated addiction to dependency producing medications
Current active implantable medical device
Cancer
Have osteoporosis
Active infection
Allergies to system components
AGE \> 80
Expected need to undergo MRI imaging in the future
Other significant comorbidities

The record

StatusUnknown

PhaseNot applicable

Taking part20

StartedJan 2022

UpdatedNov 24, 2023

Conditions

Spinal Fusion Radiculopathy Lumbar Chronic Pain

Where2

South Bend Orthopaedics
Mishawaka, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States