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

Launched by RETROPSOAS TECHNOLOGIES, LLC · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical monitoring technique called the EARP Nerve Cuff, which will be used during a specific type of back surgery known as Transforaminal Lumbar Interbody Fusion (TLIF). The goal is to see how well this new device works compared to standard nerve monitoring tools that surgeons typically use. By comparing these devices, the researchers hope to determine which one is safer and better at monitoring the nerves during surgery.

To participate in this trial, you need to be between the ages of 18 and 80 and scheduled for TLIF surgery at the L2 to S1 levels of your spine. Certain medical conditions or situations, like being pregnant or having specific allergies, may prevent you from joining. If you decide to take part, you can expect to have the new monitoring device used alongside the standard tools during your surgery, and the effectiveness and safety of both will be carefully evaluated. This study is currently looking for participants, and your involvement could help improve the safety of future surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Undergoing TLIF between L2-S1
• Exclusion 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