RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-07
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06204900

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.

Ages Eligible for Study:22 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Requiring TLIF surgery only at the L5-S1 level
  2. * Acute lumbar spine trauma requiring immediate intervention
  3. * Allergy or contraindication to propofol
  4. * Lower extremity amputation
  5. * Significant lower extremity edema noted on clinical exam
  6. * Current treatment with chemotherapy, radiation, or immunosuppression
  7. * Pregnant, or plans on becoming pregnant in the near future
  8. * History of allergy to titanium, platinum, aluminum, stainless steel, or silicon

Contacts and Locations

Study Contact

Nicholas Poulos, M.D.
CONTACT
(618) 402-0035
npoulos@retropsoas.com
Greg Ambra
CONTACT
(732) 595-7508
greg.ambra@inquiry-research.com

Principal Investigator

Nicholas Poulos, MD
STUDY_DIRECTOR
Retropsoas Technologies, LLC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Retropsoas Technologies, LLC

  • Nicholas Poulos, MD, STUDY_DIRECTOR, Retropsoas Technologies, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07
Study Completion Date2025-04

Study Record Updates

Study Start Date2024-06-07
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • TLIF Surgery

Additional Relevant MeSH Terms

  • Transforaminal Lumbar Interbody Fusion Surgery