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SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

NCT04054401•SynerFuse, Inc

Summary

The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+5 more criteria

Locations (2)

South Bend Orthopaedics

Mishawaka, Indiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

January 6, 2022

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

November 24, 2023

Enrollment

ESTIMATED participants

Conditions

Spinal FusionRadiculopathy LumbarChronic Pain

Interventions

DRG Neurostimulation with Spinal Fusion

DEVICE

Contacts

Gabi Molnar

CONTACT

612-217-2914 Gabi@SynerFuse.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

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