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Can a glue stop spinal fluid leaks after surgery?

NCT ID NCT07754344

Disease control Sponsor: Medprin Regenerative Medical Technologies Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a special medical adhesive can create a watertight seal over the spinal lining after surgery, preventing cerebrospinal fluid leaks. About 141 adults undergoing spinal surgery with confirmed fluid leakage will be randomly assigned to receive either the adhesive or standard reinforcement. The main goal is to see if the adhesive successfully stops the leak during surgery, with follow-up checks for leaks and side effects over 90 days.

What this could mean

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

Active substance
A medical adhesive applied over the sutured spinal lining to create a watertight seal and prevent cerebrospinal fluid leakage.
What this could lead to
If effective, this adhesive could reduce the risk of cerebrospinal fluid leaks after spinal surgery, potentially shortening hospital stays and improving recovery.
What could go wrong
The trial is still in Phase 3 and results are not yet known. The adhesive may not seal as well as standard methods, and there could be risks like allergic reactions or infection.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

141 people

The number who actually took part.

Started

May 2024

Finished

Jul 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

18 to 75 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: * Aged 18-75 years old, any gender. * Undergoing spinal surgery with dural incision, traumatic tear or defect requiring primary repair. * Intraoperative confirmed CSF leakage after primary dural repair via naked eye, microscopy, Valsalva maneuver or hemostatic sponge test. * Patient or legal guardian voluntarily signs written informed consent form. Exclusion Criteria: * Participated in another interventional clinical trial within 1 month before surgery. * Severe cardiac, hepatic, renal or hematological disease unable to tolerate spinal surgery. * Known hypersensitivity to any component of dural medical adhesive (polyethylenimine, 4-arm PEG succinimidyl glutarate, brilliant blue, ε-poly-L-lysine hydrochloride). * History of severe anaphylaxis or immunodeficiency disorders. * Expected survival less than 3 months post-operation. * Pregnant, lactating female or women planning pregnancy within 3 months after surgery. * Poor treatment compliance judged by investigator, unable to complete full follow-up visits. * Unable to understand trial information and cooperate with assessment. * Intraoperative dural defect that cannot receive primary sutured repair. * Class III contaminated surgical wound or active infection at operation site. * Any other condition judged inappropriate for trial participation by investigator.

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Conditions

The condition(s) this trial relates to.

Cerebrospinal Fluid Otorrhea cerebrospinal fluid leak prevention target

As listed by the trial registrant

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

Cerebrospinal fluid leakage Spinal dural defect Spinal neurosurgery

Contacts and locations

Locations

  • Nanfang Hospital, Southern Medical University

    Guangzhou, China

  • Peking University Third Hospital

    Beijing, China

  • Shenzhen Second People's Hospital

    Shenzhen, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • Xi'an Honghui Hospital

    Xi'an, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, China

More trials for these conditions

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