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New sealant aims to stop brain fluid leaks during neurosurgery

NCT ID NCT07651826

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special sealant called Immiseal that is applied during brain or spine surgery to prevent leaks of cerebrospinal fluid. It is used along with standard repair methods to create a watertight seal. The study follows adults aged 18 to 75 who need dural repair after surgery or injury. Researchers will check for infections and fluid leaks for about 100 days after the procedure.

What this could mean

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

Active substance
Immiseal Dural Sealant System
What this could lead to
If successful, this sealant could provide a reliable way to prevent cerebrospinal fluid leaks after brain or spine surgery, reducing complications.
What could go wrong
This is an observational study with a small group of 85 people, so results may not apply to everyone. Risks include infection or the sealant not working as expected.

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.

Participants

About 85 people

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

Started

Feb 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

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.

Who is studied

Adult patients aged 18 to 75 years who require dural repair following neurosurgical procedures or traumatic injury and for whom the investigator has made the clinical decision to use the Immiseal™ Dural Sealant System as an adjunct to standard methods of dural repair. Eligible patients may have dural defects associated with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, posterior fossa surgery, spinal canal disease, or other neurosurgical procedures or accidents, and may present with or be at risk of cerebrospinal fluid leakage requiring auxiliary dural repair.

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: 1. Age 18 to 75 years old, regardless of gender. 2. Patients diagnosed with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, or spinal canal disease, who undergo neurosurgical procedures such as posterior fossa surgery or other interventions resulting in dural defects, whether due to surgery or accidental injury, and who present with, or are at risk of, cerebrospinal fluid (CSF) leakage requiring auxiliary dural repair. 3. Patients willing to comply with the requirements of the clinical investigation by signing the informed consent. 4. Female patients of childbearing potential must use highly effective contraceptive methods for the duration of the study. Highly effective contraceptive methods include hormonal contraception, intrauterine device, or sexual abstinence. Exclusion Criteria: 1. Immiseal™ Dural Sealant System is not to be used in confined bone structures where nerves are present, since neural compression may result due to hydrogel swelling. 2. Patients with an active infection present at the surgical site. 3. Patients with life expectancy less than 3 months. 4. Female patients who are pregnant, planning pregnancy, breastfeeding, and/or unwilling to use adequate contraception during the trial.

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Conditions

The condition(s) this trial relates to.

brain neoplasm cerebrospinal fluid leak cerebrovascular disorder congenital nervous system disorder Surgical Wound Infection traumatic brain injury vertebral column disorder

As listed by the trial registrant

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

Cerebrospinal fluid leak Dural defect Neurosurgical procedures

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

  • Riga East Clinical University Hospital

    RECRUITING

    Riga, Latvia

More trials for these conditions

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