Clinical Trial

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

Study acronym: EARP-2
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07020000
Lead Sponsor Retropsoas Technologies, LLC
Conditions Transforaminal Lumbar Interbody Fusion Surgery
Enrollment 120 participants
Start Date 2025-08-30
Primary Completion 2027-08-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-13