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A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.

NCT06204900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery.

The Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor surgical and nerve monitoring tools will be used in addition to standard nerve monitoring tools during the surgery. The choice of standard nerve monitoring equipment is based on the decision of the surgeon and technologist and is not dictated by this study.

These tools will be compared with regards to safety and ability to accurately monitor the nervous system during the surgery.

Conditions

  • Transforaminal Lumbar Interbody Fusion Surgery

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 a standard Transforaminal Lumbar Interbody Fusion (TLIF).

Sponsors & Collaborators

  • Retropsoas Technologies, LLC

    lead INDUSTRY

Principal Investigators

  • Nicholas Poulos, MD · Retropsoas Technologies, LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2025-12-01
Completion
2025-12-01
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 NCT06204900 on ClinicalTrials.gov