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Tiny scope, big hope: new surgery aims to ease back pain without the usual side effects

NCT ID NCT07588555

Symptom relief Sponsor: The Third Affiliated Hospital of Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new, smaller surgical tool called LUSE-TLIF against the current standard minimally invasive fusion (MIS-TLIF) for people with lumbar spinal stenosis. The new tool is a flexible endoscope only 1.8 mm wide, designed to give surgeons a better view and reduce muscle damage. Researchers will compare pain, disability, and bone fusion rates in 276 adults aged 40-70 over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LUSE-TLIF (a new soft endoscope surgical procedure) compared to MIS-TLIF (standard minimally invasive surgery)
What this could lead to
If successful, this could offer a safer, more effective surgical option for lumbar spinal stenosis, potentially reducing chronic back pain and improving fusion rates.
What could go wrong
This is an early-stage, single-center trial with 276 participants. The new technique may not prove superior or could have unforeseen complications. Results may not apply to all patients.

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

About 276 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 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: * Age ranging from 40 to 70 years, irrespective of sex. * Presence of bilateral lower-limb pain and neurogenic claudication, with or without low back pain. * Preoperative computed tomography or magnetic resonance imaging confirming single-level lumbar spinal stenosis accompanied by grade II or higher lumbar spondylolisthesis and/or lumbar instability. * Persistent pain within 7 days prior to enrollment, with inadequate response to nonsurgical treatment for more than 3 months. * Willingness to provide written informed consent and ability to comply with the study protocol and visit schedule. Exclusion Criteria: * Patients with evidence of vascular claudication identified by lower-limb color Doppler ultrasound. * Patients with a history of previous lumbar spine surgery. * Coexistence of severe lumbar disc herniation, spinal deformity, spinal tumor, infection, or inflammatory diseases. * Pregnancy or lactation. * Presence of severe underlying medical conditions or psychiatric disorders that preclude tolerance of the procedure. * Known concurrent diseases considered by the investigator to preclude study entry. * Inability to comply with study assessments or complete questionnaires for any reason. * Patients deemed unsuitable for participation in this trial as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

lumbar spinal stenosis spinal stenosis spondylolisthesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lumbar spinal stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Third Affiliated Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 515000, China

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