New device aims to protect nerves during back surgery
NCT ID NCT06204900
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called the EARP Nerve Cuff and Retractor, designed to monitor nerve activity during TLIF spine surgery. Five patients received the device alongside standard monitoring tools. Researchers compared how well each method detected nerve irritation, aiming to improve surgical safety. The study is complete, but results are not yet widely available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor System
- What this could lead to
- If successful, this device could help surgeons better protect nerves during spine surgery, potentially reducing the risk of nerve injury.
- What could go wrong
- This was a very small study (5 people) with no control group, so results may not apply widely. The device is still experimental and not yet proven to be better than standard monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
5 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
22 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
-
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States