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

Conditions

• Transforaminal Lumbar Interbody Fusion Surgery

Eligibility Criteria

Sex

ALL

Age

22 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Device: Nerve Cuff and Retractor System — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Aug 30, 2025

Status verified

Jun 2025

Primary completion

Aug 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

120 participants (estimated)

Primary Outcome Measure

Radiographic measurements prior to surgery and at follow-up visits [ Time Frame: From enrollment until the end of follow-up at 12 months ]

Central Contacts

• Medical Director
  618-402-0035
  [email protected]

Locations (3)

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