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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

NCT07020000 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-06-13

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Retropsoas Technologies, LLC

    lead INDUSTRY

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2027-08-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020000 on ClinicalTrials.gov