NCT07020000View on ClinicalTrials.gov

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

Not yet recruitingOBSERVATIONAL

Enrollment

120

Participants

Timeline

Start Date

August 30, 2025

Primary Completion Date

August 30, 2027

Study Completion Date

September 30, 2027

Conditions

Transforaminal Lumbar Interbody Fusion Surgery

Interventions

DEVICE

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.

Trial Locations (3)

10591

Northwell/Phelps, Sleepy Hollow

15212

Alleghany Health Network, Pittsburgh

19107

Rothman Orthopaedic Institute, Philadelphia

All Listed Sponsors

lead

Retropsoas Technologies, LLC

INDUSTRY