New device aims to protect nerves during back surgery

NCT ID NCT06204900

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania, 19107, United States