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

Description

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

Study Overview

Study Details

Study overview

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.

Evaluation of a Novel Technique to Monitor Neurophysiological Activity During TLIF Surgery Using the Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor with a Commercially Available Lumbar Spine Retractor System

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

Condition
Transforaminal Lumbar Interbody Fusion Surgery
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States, 15212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Requiring TLIF surgery only at the L5-S1 level
  • * Acute lumbar spine trauma requiring immediate intervention
  • * Allergy or contraindication to propofol
  • * Lower extremity amputation
  • * Significant lower extremity edema noted on clinical exam
  • * Current treatment with chemotherapy, radiation, or immunosuppression
  • * Pregnant, or plans on becoming pregnant in the near future
  • * History of allergy to titanium, platinum, aluminum, stainless steel, or silicon

Ages Eligible for Study

22 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Retropsoas Technologies, LLC,

Nicholas Poulos, MD, STUDY_DIRECTOR, Retropsoas Technologies, LLC

Study Record Dates

2025-04