A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF 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
Retropsoas Technologies, LLC
30 participants
Jun 7, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Undergoing TLIF between L2-S1
Exclusion Criteria8
- 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
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Interventions
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).
Locations(2)
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NCT06204900