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The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
Sponsor: Retropsoas Technologies, LLC
Summary
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures. The primary objectives are: * To evaluate the safety of the EARP surgical technique and devices during LIF surgeries. * To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.
Official title: A Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-08-30
Completion Date
2027-09-30
Last Updated
2025-06-13
Healthy Volunteers
No
Interventions
Device: Nerve Cuff and Retractor System
Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and an EARP Retractor system to safely monitor lumbar nerve root activity and function during standard interbody fusion surgeries.
Locations (3)
Northwell/Phelps
Sleepy Hollow, New York, United States
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Alleghany Health Network
Pittsburgh, Pennsylvania, United States