NCT04054401

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: SynerFuse, Inc · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Fusion
• Radiculopathy Lumbar
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	DRG Neurostimulation with Spinal Fusion	Surgeons will implant a neurostimulator during the same open back procedure as fusion devices (spinal fusion hardware and interbody cage) and begin neurostimulation in a short time following surgery (24 hours).

Timeline

• Start date: 2022-01-06
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2019-08-13
• Last updated: 2023-11-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study