SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
Unknown statusNot applicableNCT04054401
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
- Conditions
- Spinal Fusion
- Radiculopathy Lumbar
- Chronic Pain
- Interventions
- Device: DRG Neurostimulation with Spinal Fusion
- Sponsor
- SynerFuse, Inc
- Start date
- 2022-01-06
- Primary completion
- 2024-10
- Sex
- All
- Age range
- from 21 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 * Active infection * Allergies to system components * AGE \> 80 * Expected need to undergo MRI imaging in the future * Other significant comorbidities
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04054401